Evaluating the Effect of Intravenous Acetaminophen in Multimodal Analgesia After Total Hip Arthroplasty: A Randomized Controlled Trial

BackgroundPostoperative pain is a significant concern of patients before surgery. Multimodal pain management is an effective method of pain control after major orthopedic surgery. Acetaminophen is the most commonly used analgesic for the management of pain. It was hypothesized that 1000 mg of intravenous acetaminophen (IA) dosed every 6 hours would significantly reduce the postoperative pain score at rest and the opioid consumption volume in patients who would undergo total hip arthroplasty (THA) when compared to a control group.MethodsA single-center, prospective, open-label randomized control study was conducted. A total of 97 patients undergoing unilateral primary THA were divided into 2 groups: the study group (IA) (n = 45) and the control group (n = 52). The study group received administered IA after surgery, while the control group received only a standard pain control. Both groups received a preoperative femoral nerve block and postoperative intravenous fentanyl citrate. The primary outcome was the evaluation of the pain score at rest 24 hours after surgery. The pain score was measured using the Numerical Rating Scale. The primary outcome of this study was analyzed using generalized estimating equation.ResultsThe IA group had a significant improvement in Numerical Rating Scale score at rest 24 hours after THA compared to the control group (−0.91, 95% confidence interval −1.56 to −0.26, P = .006), suggesting a positive effect of IA usage for pain relief. The total fentanyl citrate consumption after surgery for 24 hours was significantly lower in the IA group than those of the control group (52.07 ± 7.64 vs 57.83 ± 12.44 mg, P < .001).ConclusionPostoperative administration of IA significantly reduced the postoperative pain score and opioid consumption volume after primary THA. IA was useful as one role of multimodal pain management after THA.Level of Evidence: Level 2.     

The Fragility of Statistically Significant Findings From Randomized Controlled Trials in Hip and Knee Arthroplasty

BackgroundThe Fragility Index (FI) is a method for evaluating the robustness of statistically significant findings from randomized controlled trials (RCTs) beyond the P value in trials with dichotomous outcomes. The FI is defined as the number of patients in one arm of a trial that would have to have a different outcome to change the results of the trial from statistically significant to nonsignificant. This review assessed the FI in arthroplasty RCTs.MethodsA systematic search was conducted in MEDLINE, Embase, and Web of Science for RCTs related to primary total joint arthroplasty (TJA) from 2010 to 2020. Trials with a statistically significant dichotomous primary outcome were included. The FI was calculated using Fisher’s exact test to determine how many events would need to be reversed to change a study from statistically significant to nonsignificant.ResultsA total of 34 RCTs were included. The median sample size was 103 patients (range 24-791). The median FI was 1 (range 0-45), meaning that reversing the outcome of just one patient in either treatment group of each trial would change it from a significant to a nonsignificant result.ConclusionHip and knee arthroplasty RCTs with statistically significant dichotomous outcomes in TJA are fragile. The median FI in TJA is lower than the FI in any of the other previously reported orthopedic subspecialties. Fragility is another reason to be cautious when conducting or interpreting small trials, and to continue to strive toward large trials to answer important questions in TJA.Level of EvidenceLevel I.     

Characterization and Potential Relevance of Randomized Controlled Trial Patient Populations in Total Joint Arthroplasty in the United States: A Systematic Review

BackgroundA substantial number of randomized controlled trial (RCT) studies in total joint arthroplasty (TJA) are published each year in the United States (US). However, it is unknown how closely the demographic and clinical characteristics of these cohorts resemble that of the US patient population undergoing TJA. Thus, the purpose of this systematic review was to evaluate the patient characteristics of published RCTs in TJA in the US and to compare these characteristics against patient cohorts from national patient databases.MethodsRCT studies regarding primary TJA conducted in the US were selected. Key patient demographics were aggregated and compared against demographics characteristics of the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality National Inpatient Sample (NIS) and American College of Surgeons National Surgical Quality Improvement Program patient cohorts.ResultsOne hundred and fifty-three RCTs fulfilled the inclusion criteria and were included. The total number of patients in the 153 RCTs was 24,135 patients. The average age of patients in the TJA RCT cohort was 65 years (53-80) while the NIS cohort was 67 years (18-90) (d = 0.21, effect size = small). The average body mass index of the TJA RCT cohort was 30.8 (18.2-37.6) while the National Surgical Quality Improvement Program cohort was 31.9 (14.1-59.6) (d = 0.18, effect size = small). For TJA, effect sizes for age, body mass index BMI, sex, ethnicity, smoking, and diabetes were all small or very small.ConclusionOverall, the US RCT patient cohort for TJA does not differ substantially from the general patient population undergoing TJA in the United States. Differences in demographic and clinical characteristics between the TJA RCT cohort and database cohorts ranged from minimal to small, suggesting that these differences are unlikely to impact clinical outcomes.     

A Prospective Randomized Controlled Trial Comparing Medial-Pivot versus Posterior-Stabilized Total Knee Arthroplasty

BackgroundThe medial-pivot (MP) design for total knee arthroplasty (TKA) aims to restore more natural “ball-and-socket” knee kinematics compared to the traditional posterior-stabilized (PS) implants for TKA. The objective of this study is to determine if there was any difference in functional outcomes between patients undergoing MP-TKA vs PS-TKA.MethodsThis prospective randomized controlled trial consisted of 43 patients undergoing MP-TKA vs 45 patients receiving a single-radius PS-TKA design. The primary outcome was postoperative range of motion (ROM). Secondary outcomes included the Western Ontario and McMaster Universities Arthritis Index, Oxford Knee Score, Knee Society Score (KSS), and radiological outcomes. All study patients were followed-up for 2 years after surgery.ResultsPatients undergoing MP-TKA had comparable ROM at 1 year (114.6° ± 16.3° vs 111.3° ± 17.8° respectively, P = .88) and 2 years after surgery (114.9° ± 15.5° vs 114.9° ± 16.4° respectively, P = .92) compared to PS-TKA. There were also no differences in Western Ontario and McMaster Universities Arthritis Index (26.8 ± 19.84 vs 22.0 ± 12.03 respectively, P = .14), Oxford Knee Score (42.7 ± 8.1 vs 42.3 ± 6.7 respectively, P = .18), KSS clinical scores (82.9 ± 16.96 vs 81.42 ± 10.45 respectively, P = .12) and KSS functional scores (76.2 ± 18.81 vs 73.93 ± 8.53 respectively, P = .62) at 2-year follow-up. There was no difference in postoperative limb alignment or complications.ConclusionThis study demonstrated excellent results in both the single-radius PS-TKA design and MP-TKA design. No differences were identified at 2-year follow-up with respect to postoperative ROM and patient-reported outcome measures.     

Intraoperative Psoas Compartment Block vs Preoperative Fascia Iliaca Block for Pain Control After Direct Anterior Total Hip Arthroplasty: A Randomized Controlled Trial

Background

Modern joint arthroplasty protocols place an emphasis on minimizing patient-reported postoperative pain while minimizing opioid consumption. The use of multimodal pain management protocols has been reported to improve patient outcomes and satisfaction after total hip arthroplasty.

Repeat Doses of Dexamethasone up to 48 Hours Further Reduce Pain and Inflammation After Total Hip Arthroplasty: A Randomized Controlled Trial

BackgroundThe optimal dose regimen of dexamethasone in total hip arthroplasty (THA) is unclear. This study was conducted to compare the effects among 1-dose, 2-dose, and 3-dose dexamethasone in THA.MethodsOne hundred fifty patients were randomized to receive a single preoperative dose of 10-mg dexamethasone (group A, 50 patients), or another dose of 10-mg dexamethasone 24 hours later (group B, 50 patients), or another 2 doses of 10-mg dexamethasone 24 and 48 hours later (group C, 50 patients). The primary outcome was postoperative pain level. The use of analgesic and antiemetic rescue; incidence of postoperative nausea and vomiting; C-reactive protein and interleukin-6 levels; range of motion; and complications were also compared.ResultsThe dynamic pain scores were lower for groups B and C compared to group A on postoperative days 2 and 3. Such difference was also detected between groups B and C on postoperative day 3. C-reactive protein and interleukin-6 levels were lower in groups B and C than in group A at 48 and 72 hours postoperatively. Such difference was also observed between groups B and C at 72 hours postoperatively. Patients in groups B and C had reduced rescue analgesic use, and improved range of motion compared to patients in group A. There were no differences among 3 groups regarding the rescue antiemetic use, postoperative nausea and vomiting occurrence, and complications.ConclusionAdditional administrations of dexamethasone after THA could provide sustained pain relief and inflammatory control. Besides, the 3-dose regimen was more effective than the 2-dose regimen in terms of the analgesic and anti-inflammatory effects.Level of EvidenceI     

Component Placement in Direct Lateral vs Minimally Invasive Anterior Approach in Total Hip Arthroplasty: Radiographic Outcomes From a Prospective Randomized Controlled Trial

BackgroundEnd-stage coxarthrosis is increasingly common; however, limited evidence exists on the effect of direct lateral approach (DLA) and minimally invasive direct anterior approach (MIDA) on component placement in total hip arthroplasty (THA). We therefore conducted a prospective, randomized controlled trial to determine the component placement in DLA vs MIDA in THA.MethodsBetween January 2012 and June 2013, 164 patients with clinically and radiologically confirmed coxarthrosis aged 20-80 years were randomized to either DLA or MIDA (active comparator). Excluded were patients with previous ipsilateral hip surgery, a body mass index >35 kg/m², and/or mental disability. Primary clinical outcomes have been published elsewhere. Secondary outcomes included radiographic assessment of the acetabular component (cement-mantle thickness, inclination, and anteversion), femoral stem position (varus/valgus and THA index), offset restoration, and leg length discrepancy.ResultsThe mean cement-mantle was significantly thicker in zone 1 in the MIDA group (mean difference = 0.51 mm, 95% confidence interval [CI] 0.09-0.93, P = .018), and the mean degrees of inclination and anteversion were higher in the MIDA group (mean difference = 2.5°, 95% CI 0.3-4.6, P = .023 and mean difference = 3.6°, 95% CI 2.2-5.0, P < .0001, respectively). According to the defined reference range, cup inclination was more often adequate in the DLA group (67.9% (53/78) in the DLA group vs 52.4% (43/82) in the MIDA group, P = .045). There were no differences in frontal or lateral femoral stem position, global offset restoration, or leg length discrepancy.ConclusionIn this population of Norwegian patients with coxarthrosis, radiographic assessment showed limited differences in component placement between MIDA and DLA. The findings suggest that component placement is similar in the 2 surgical approaches.     

Efficacy of Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia After Hip Arthroplasty: A Meta-Analysis of Randomized Controlled Trials

BackgroundUltrasound-guided quadratus lumborum (QL) block as a novel regional anesthetic technique was proposed in 2007 that can be applied in patients following hip arthroplasty. This study aimed to evaluate the efficacy of the QL block for pain control in patients undergoing hip arthroplasty.MethodsWe performed a comprehensive search of PubMed, Web of Science, Scopus, Cochrane Library, Embase databases, Google Scholar, and CNKI for randomized controlled trials up to December 2021. According to the inclusion and exclusion criteria established in advance, “QL block” and “hip arthroplasty” related MeSH terms and free-text words were used.ResultsOur meta-analysis included 11 randomized controlled trials involving a total of 830 patients between 2018 and 2021. The results indicated that compared to the non-QL block group, Visual Analog Scale (VAS) score at mobilization in the QL block group demonstrated statistical and clinical significance at all time points (12, 24, and 48 hours), but VAS score at rest failed to reach the MCID (minimal clinically important difference). Meanwhile, opioid consumption in the QL block group only demonstrated statistical and clinical significance at 48 hours postoperatively, but did not reach the MCID at 12 or 24 hours postoperatively. The QL block increased satisfaction scores. There was a statistically significant reduction in the incidence of postoperative nausea and vomiting, but no difference in the incidence of pruritus and urinary retention.ConclusionThe QL block significantly reduced postoperative VAS score at mobilization, and opioid consumption at 48 hours in patients after hip arthroplasty compared to no block, which reached the MCID. The QL block also decreased postoperative nausea and vomiting and increased satisfaction scores. Although these are promising results, the clinical relevance of the efficacy of the QL block remains to be further understood as larger studies are needed.     

Comparison of Early-Stage and Late-Stage Periarticular Injection for Pain Relief After Total Hip Arthroplasty: A Double-Blind Randomized Controlled Trial

BackgroundNo randomized controlled trial has investigated a more optimal timing of periarticular injection for pain relief after total hip arthroplasty.MethodsThe study included 140 patients, and these patients were randomly allocated to the early-stage (periarticular injection was performed just before arthrotomy, and placebo was injected after implantation) or late-stage (placebo was injected just before arthrotomy, and periarticular injection was performed after implantation) injection groups. Other perioperative interventions were similar in all participants. The prespecified primary outcome was postoperative pain score at the recovery room.ResultsThe visual analog scale score at the recovery room of the early-stage injection group was significantly lower than that of the late-stage injection group (30 ± 28 vs 46 ± 30 mm; 95% CI, −25 to −5 mm; P = .0022), and this difference reaches a minimal clinically important difference level of 10 mm. No differences were observed with regard to complication rate.ConclusionEarly-stage periarticular injection during total hip arthroplasty provided better postoperative pain relief than late-stage periarticular injection without elevating complication rate.Level of EvidenceLevel I, randomized controlled trial.     

Portable Accelerometer-Based Navigation System for Cup Placement of Total Hip Arthroplasty: A Prospective,Randomized, Controlled Study

BackgroundMalposition of the acetabular component during total hip arthroplasty (THA) is associated with increased risk of dislocation, reduced range of motion, and accelerated wear. The purpose of this study is to compare cup positioning with a portable, accelerometer-based hip navigation system and conventional surgical technique.MethodsIn a prospective, randomized, clinical study, cups were implanted with a portable, accelerometer-based hip navigation system (navigation group; n = 55) or conventional technique (conventional group; n = 55). THA was conducted in the lateral position and through posterior approach. The cup position was determined postoperatively on pelvic radiograph and computed tomography scans.ResultsAn average cup abduction of 39.2° ± 4.6° (range, 27° to 50°) and an average cup anteversion of 14.6° ± 6.1° (range, 1° to 27.5°) were found in the navigation group, and an average cup abduction of 42.9° ± 8.0° (range, 23° to 73°) and an average cup anteversion of 11.6° ± 7.7° (range, −12.1° to 25°) in the conventional group. A smaller variation in the navigation group was indicated for cup abduction (P = .001). The deviations from the target cup position were significantly lower in the navigation group (P = .001, .016). While only 37 of 55 cups in the conventional group were inside the Lewinnek safe zone, 51 of 55 cups in the navigation group were placed inside this safe zone (P = .006). The navigation procedure took a mean of 10 minutes longer than the conventional technique.ConclusionUse of the portable, accelerometer-based hip navigation system can improve cup positioning in THA.     

Causes of Revision in Young Patients Undergoing Total Hip Arthroplasty

BackgroundThe purpose of this study was to identify reasons for revision of total hip arthroplasty (THA) in patients who underwent primary THA at or before the age of 35 years. We hypothesized that the reasons for revision in younger patients would be different from the general older population of patients undergoing THA because of the differences in diagnoses, complexity of deformities, and differences in activity level.MethodsData for 108 hips in 82 patients who underwent primary THA at our institution before the age of 35 years from 1982-2007 and subsequently underwent revision THA were reviewed. Operative reports and clinic notes were reviewed to determine baseline characteristics, reason for revision, timing of revision, and components revised.ResultsThe mean age at index surgery was 25.4 years, and mean time from index to revision surgery was 10.1 years. The most common preoperative diagnoses included avascular necrosis, juvenile idiopathic arthritis, developmental dysplasia of the hip, and posttraumatic arthritis. The most common reasons for revision were acetabular loosening (30.1%), femoral loosening (23.7%), and polyethylene wear (24.7%). 8.3% of patients underwent primary THA with highly cross-linked polyethylene, while the remainder of the patients underwent THA when conventional polyethylene was used. There was no statistically significant association between which component(s) were revised and initial fixation (ie cemented or uncemented prosthesis) (P = .26).ConclusionCauses of revision in this population appear to differ from the general THA population. In young patients, acetabular loosening, femur loosening, and polyethylene wear were the most common causes of revision. Instability and infection were less common compared with literature reports of causes of revision in older patients. Findings in this study may be useful in counseling young patients undergoing THA, though results were likely influenced by the use of conventional rather than highly cross-linked polyethylene in this cohort.     

A Randomized Controlled Trial of Intraarticular Ropivacaine for Pain Management Immediately Following Total Knee Arthroplasty

Total knee arthroplasty (TKA) is a commonly performed procedure for the treatment of end-stage arthritis of the knee. Pain control following TKA is difficult to manage in some patients. We examined the use of a postoperative intraarticular injection of 100 mL of 0.2% (200 mg) ropivacaine in a double-blind, prospective, placebo-controlled pilot study to evaluate its use as a pain control modality. All patients received general anesthesia. Postoperatively, patients were placed on intravenous patient-controlled analgesia with morphine. The ropivacaine group showed an early trend in lower visual analog scale (VAS) scores when compared with the placebo group. Patients receiving ropivacaine used a similar amount of narcotics compared with the placebo group. Intraarticular ropivacaine used for pain control after TKA demonstrated no statistically significant difference in lowering VAS scores or narcotic usage; therefore, intraarticular ropivacaine as a single modality is not recommended for effective pain management.     

Randomized Controlled Trial of Sensor-Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty

BackgroundDespite advances in total knee arthroplasty (TKA) technology, up to 1 in 5 patients remain dissatisfied. This study sought to evaluate if sensor-guided knee balancing improves postoperative clinical outcomes and patient satisfaction compared to a conventional gap balancing technique.MethodsWe undertook a prospective double-blind randomized controlled trial of patients presenting for elective primary TKA to determine a difference in TKA soft tissue balance between a standard gap balancing (tensiometer) approach compared to augmenting the balance using a sensor-guided device. The sensor-guided experimental group had adjustments made to achieve a balanced knee to within 15 pounds of intercompartmental pressure difference. Secondary outcomes included differences in clinical outcome scores at 6 months and 1 year postoperative, including the Oxford Knee Score and Knee Society Score and patient satisfaction.ResultsThe sample comprised of 152 patients, 76 controls and 76 experimental sensor-guided cases. Within the control group, 36% (27/76) of knees were unbalanced based on an average coronal plane intercompartmental difference >15 pounds, compared to only 5.3% (4/76) within the experimental group (P < .0001). There were no significant differences in 1-year postoperative flexion, Knee Society Score, or Oxford scores. Overall, TKA patient satisfaction at 1 year was comparable, with 81% of controls and experimental cases reporting they were very satisfied (P = .992).ConclusionDespite the use of the sensor-guided knee balancer device to provide additional quantitative feedback in the evaluation of the soft tissue envelope during TKA, we were unable to demonstrate improved clinical outcomes or patient satisfaction compared to our conventional gap balancing technique.     

Perioperative Use of Gabapentinoids and Risk for Postoperative Long-Term Opioid Use in Older Adults Undergoing Total Knee or Hip Arthroplasty

BackgroundGabapentinoids are recommended by guidelines as a component of multimodal analgesia to manage postoperative pain and reduce opioid use. It remains unknown whether perioperative use of gabapentinoids is associated with a reduced or increased risk of postoperative long-term opioid use (LTOU) after total knee or hip arthroplasty (TKA/THA).MethodsUsing Medicare claims data from 2011 to 2018, we identified fee-for-service beneficiaries aged ≥ 65 years who were hospitalized for a primary TKA/THA and had no LTOU before the surgery. Perioperative use of gabapentinoids was measured from 7 days preadmission through 7 days postdischarge. Patients were required to receive opioids during the perioperative period and were followed from day 7 postdischarge for 180 days to assess postoperative LTOU (ie, ≥90 consecutive days). A modified Poisson regression was used to estimate the relative risk (RR) of postoperative LTOU in patients with versus without perioperative use of gabapentinoids, adjusting for confounders through propensity score weighting.ResultsOf 52,788 eligible Medicare older beneficiaries (mean standard deviation [SD] age 72.7 [5.3]; 62.5% females; 89.7% White), 3,967 (7.5%) received gabapentinoids during the perioperative period. Postoperative LTOU was 3.8% in patients with and 4.0% in those without perioperative gabapentinoids. After adjusting for confounders, the risk of postoperative LTOU was similar comparing patients with versus without perioperative gabapentinoids (RR = 1.07; 95% confidence interval [CI] = 0.91-1.26, P = .408). Sensitivity and bias analyses yielded consistent results.ConclusionAmong older Medicare beneficiaries undergoing a primary TKA/THA, perioperative use of gabapentinoids was not associated with a reduced or increased risk for postoperative LTOU.     

Capsular Management in Direct Anterior Total Hip Arthroplasty: A Randomized,Single-Blind,Controlled Trial

BackgroundThe direct anterior approach (DAA) is a popular approach to total hip arthroplasty (THA). Unlike the posterior approach, the importance of anterior capsular management is unknown. This randomized controlled trial compares capsular repair versus capsulectomy.MethodsThis single-surgeon, single-blinded, parallel-group randomized controlled trial occurred between 2013 and 2016. Patients undergoing unilateral, primary THA for osteoarthritis consented to undergo blinded, simple randomization to anterior capsulotomy with repair or anterior capsulectomy. Primary outcome measures included hip range of motion, hip flexion strength, and pain with seated hip flexion. Secondary outcome measures included surgical time, estimated blood loss, postoperative complications, and hip disability and osteoarthritis outcome score. Data were prospectively collected intraoperatively, six weeks, six months, an average of over 5 years postoperatively.ResultsNinety-eight patients were ultimately enrolled in the trial; 50 received capsulectomy and 48 received capsulotomy. No significant differences were seen in preoperative demographics or in primary or secondary outcomes during this study. No difference was seen in pain at final follow-up at average > 5 years postoperatively.ConclusionThis study demonstrates that capsular management in DAA THA does not affect postoperative pain or range of motion. The anterior capsule’s role in prosthetic stability after DAA THA remains uncertain, but it does not currently appear that repair provides benefit and may lead to increased surgical time and blood loss. As such, capsular management in DAA THA is at surgeon discretion.     

Intravenous Acetaminophen in Multimodal Pain Management for Patients Undergoing Total Knee Arthroplasty: A Randomized,Double-Blind,Placebo-Controlled Trial

Background

Although multimodal pain management including periarticular multidrug injection can provide excellent pain relief in the early postoperative period after total knee arthroplasty (TKA), rebounding pain remains an important challenge. A randomized, double-blind, placebo-controlled trial was performed to investigate the efficacy of adding intravenous acetaminophen to multimodal pain management for TKA.

Multiple Doses of Perioperative Dexamethasone Further Improve Clinical Outcomes After Total Knee Arthroplasty: A Prospective,Randomized, Controlled Study

Background

This study aimed to evaluate the effect and safety of multiple doses of preoperative dexamethasone on pain and recovery after total knee arthroplasty (TKA).

Can Arthroplasty Stem Influence Outcome: A Randomized Controlled Trial of Stem Length in Cemented Total Hip Arthroplasty

BackgroundThe primary aim was to assess whether a short (125 millimeter (mm)) stem offered an equivalent hip-specific function compared to the standard (150 mm) stem when used for cemented total hip arthroplasty. Secondary aims were to evaluate health-related quality of life, patient satisfaction, stem height and alignment, as well as radiographic loosenings and complications between the two stems.MethodsA prospective twin-center double-blind randomized control trial was conducted. During a 15-month period, 220 patients undergoing total hip arthroplasty were randomized to either a standard (n = 110) or a short (n = 110) stem. There were no significant (P ≥ .065) differences in preoperative variables between the groups. Functional outcomes and radiographic assessment were undertaken at a mean of 1 and 2 years.ResultsThere were no differences (P = .428) in hip-specific function according to the mean Oxford hip scores at 1 year (primary endpoint) or at 2 years (P = .622) between the groups. The short stem group had greater varus angulation (0.9 degrees, P = .003) when compared to the standard group and were more likely (odds ratio 2.42, P = .002) to have varus stem alignment beyond one standard deviation from the mean. There were no significant (P ≥ .083) differences in the forgotten joint scores, EuroQol-5-Dimension, EuroQol-visual analogue scale, short form 12, patient satisfaction, complications, stem height, or radiolucent zones at 1 or 2 years between the groups.ConclusionThe cemented short stem used in this study had equivalent hip-specific function, health-related quality of life, and patient satisfaction when compared to the standard stem at mean 2 years post operation. However, the short stem was associated with a greater rate of varus malalignment, which may influence future implant survival.     

新型国产髋关节假体用于人工髋关节置换的随机对照研究

目的 通过随机对照临床试验,评价一种新型国产髋关节假体用于人工全髋关节置换术(total hip arthroplasty,THA)的临床疗效和安全性.方法 本研究采用多中心、随机、单盲、阳性平行对照设计,在全国5家医院共招募72例受试者,分别纳入试验组和对照组,各36例.试验组使用新型国产髋关节假体,对照组使用成熟的...