"Custom-fit" versus "off-the-shelf" ACL functional braces

Many sports medicine practitioners believe "custom-fit" functional braces are superior in performance to "off-the-shelf" braces for anterior cruciate ligament (ACL)-deficient knees. However, this is not well substantiated. This study compares a Donjoy custom-fit ACL brace (CE 2000), Donjoy off-the-shelf brace (Goldpoint), and an athletic taping technique to determine their role in our clinical practice. Five patients (3 men and 2 women) with isolated, unilateral, chronic ACL tears with an average age of 27 years (range: 19-35 years) were used to evaluate these three restraint systems. Anterior tibial laxity, quadriceps and hamstrings strength, endurance, standing long jump, brace migration with exercise, and pattern of muscle response to forced anterior tibial displacement were studied. Each patient was tested without a brace and then in each of the three test conditions (custom brace, off-the-shelf brace, and tape), with the order of testing randomized. The Donjoy custom-fit ACL functional brace did not reduce anterior laxity or improve standing long jump, muscle strength, endurance, or muscle response times significantly more than the off-the-shelf ACL brace. Both braces improved anterior stability over knee taping when the knee muscles were contracted under the low forces used in this study. After 1 hour of exercise, brace migration was significantly greater (P=.03) for the CE-2000 custom brace (18.6 mm) than for the Goldpoint off-the-shelf brace (4.5 mm). There appears to be no advantage to the more expensive custom-fit knee brace over the off-the-shelf brace.     

The effectiveness of self-adjustable custom and off-the-shelf bracing in the treatment of varus gonarthrosis

BACKGROUND: A recent development in valgus-producing knee braces has been the adjustable "unloader" brace. The purpose of this study was to compare the effectiveness of off-the-shelf and custom-made patient-adjustable, valgus-producing knee unloader braces in relieving pain, reducing stiffness, and improving function and in reducing varus angulation and the peak adduction moments about the knee during gait and stair-stepping in patients with painful varus gonarthrosis of the knee. METHODS: Ten adult patients served as their own controls for the measurement of baseline values and then wore each of the two braces, one after the other, for four to five weeks in a random order. Pain, stiffness, and function were assessed with the Western Ontario and McMaster Universities Osteoarthritis Index. Gait and stair-stepping were evaluated with a three-dimensional motion analysis system and multicomponent force platform. Full-length (hip, knee, and ankle) standing anteroposterior radiographs were used to determine alignment of the knee. RESULTS: Both braces significantly reduced pain and stiffness (p<0.05), with the custom brace reducing stiffness significantly more than the off-the-shelf brace (p=0.030). The custom brace significantly improved function (p=0.010) and reduced the peak knee adduction moments during gait (p=0.033) and stair-stepping (p=0.002) compared with baseline values and compared with the off-the-shelf brace (p=0.029 and p=0.027, respectively). The custom brace significantly reduced varus angulation of the knee by 1.5 degrees compared with baseline (p=0.001) and by 1.3 degrees compared with the off-the-shelf brace (p=0.009). The off-the-shelf brace did not significantly reduce the varus angle. CONCLUSIONS: We investigated only the short-term effects of custom and off-the-shelf patient-adjustable valgus-producing knee "unloader" braces and found that patients with varus gonarthrosis of the knee may benefit significantly with respect to pain relief and reduced stiffness from use of either brace. However, such patients may experience additional significant benefit in improved function and reduced stiffness, varus angulation, and medial compartment loading of the knee from use of the custom-made patient-adjustable brace.     

The use of functional knee braces in the control of pathologic anterior knee laxity

Four designs of knee braces, Don-Joy 4 Point, RKS, Lenox Hill, and CTi, were evaluated in 42 patients with a unilateral knee brace. Brace migration was the predominant complaint, as noted in patient questionnaires. All braces tested reduced giving-way episodes (34 of 42 patients reported no giving way during brace usage). All four brands of braces reduced the grade of pivot shift (mean reduction = 0.8 grade). Instrumented laxity testing with the KT-1000 arthrometer was performed with an 89-N passive anterior displacement, high load passive anterior displacement, and a quadriceps contraction active displacement. Brace use decreased the measured pathologic anterior displacement on all tests. During functional testing with one-legged hop and 40-yard shuttle run, the mean values were not significantly changed by brace usage.     

The effect of functional knee-braces on strain on the anterior cruciate ligament in vivo.

Functional knee-braces are widely used to protect injured or reconstructed anterior cruciate ligaments, despite the fact that few scientific data support their efficacy. We studied seven functional braces, representative of both the typical custom-fit and off-the-shelf designs. The braces were tested on subjects who had a normal anterior cruciate ligament and were scheduled for arthroscopic meniscectomy or exploration of the knee under local anesthesia. After the operative procedure, a Hall-effect strain-transducer was applied to the anterior cruciate ligament. Under low anterior shear loads, two braces provided some protective strain-shielding effect compared with no brace, but this strain-shielding effect did not occur at the higher anterior shear loads expected during the high-stress activities common to athletic events. The DonJoy, Townsend, C.Ti., and Lenox Hill braces demonstrated a strain-shielding effect on the anterior cruciate ligament with an internal torque of five newton-meters applied to the tibia. None of the braces had any effect on strain on the anterior cruciate ligament during active range of motion of the knee from 10 to 120 degrees or during isometric contraction of the quadriceps. Wearing of a brace did not produce an increase in the value for strain on the anterior cruciate ligament. For the activities that were evaluated in this study, none of the braces produced adverse effects on the anterior cruciate ligament, and there were no significant differences in the strain on the anterior cruciate ligament between the use of a custom-fit or an off-the-shelf brace design. There were no apparent advantages of the more expensive custom-made braces compared with the off-the-shelf designs.     

Three-month efficacy of three knee braces in the treatment of medial knee osteoarthritis in a randomized crossover trial

Immediate biomechanical and functional effects of knee braces are often reported, however, the duration and type of knee brace treatment for knee osteoarthritis (KOA) remain unclear. The objective was to evaluate usage, comfort, pain, and knee adduction moment (KAM) of three knee braces each worn 3 months by patients. Twenty-four patients with KOA were assigned in a randomized crossover trial a valgus three-point bending system brace (V3P-brace), an unloader brace with valgus and external rotation functions (VER-brace) and a stabilizing brace used after ligament injuries (ACL-brace). Functional questionnaires and gait assessment were carried out before and after each brace wear period of 3 months. A Friedman test was applied between brace wear diary recordings. Repeated measures analyses of variance contrasted the factors brace type (ACL, V3P, and VER), time (pre and post) and wear (without and with) on comfort, pain, function, and KAM. Brace usage was similar, but the V3P-brace was slightly less worn. Discomfort was significantly lowered with the VER-brace. All knee braces relieved pain and symptoms from 10% to 40%. KAM angular impulse was reduced with the three braces, but the VER-brace obtained the lowest relative reduction of 9%. The interaction between time and wear indicated that part of the KAM reduction with brace wear was maintained post treatment. All three knee braces have great benefits for pain and function among the medial KOA population. The VER-brace offers additional advantages on daily use, comfort and KAM, which could improve compliance to brace treatment.     

Functional testing of braces for anterior cruciate ligament-deficient knees

Previous studies into the efficacy of bracing anterior cruciate ligament (ACL)-deficient knees have lacked objective functional testing. In this study of function the authors compare the effectiveness of three custom-made and three off-the-shelf braces in stabilizing symptomatic, unilateral, chronic, non-reconstructed, ACL-deficient knees. Ten subjects randomly performed six functional tests with each of the six test braces. Knee function was evaluated both objectively and subjectively. Two customized functional braces (Generation II Polyaxial Knee Cage and Lenox Hill Derotation Brace) provided the most objective improvement during ACL-dependent activities and also the most subjective stability. Laterally hinged braces were as effective as the more commonly used double-hinged models. Based on this study, the authors recommend the use of laterally hinged customized functional braces in the nonoperative treatment of the symptomatic ACL-deficient knee.     

A biomechanical evaluation of the Lenox Hill knee brace

This study was conducted to determine the effectiveness of the Lenox Hill knee brace in limiting anterior translation and external rotation of the tibia in reference to the femur in normal and ligament-deficient knees. Four fresh cadaver knees were fitted with Lenox Hill knee braces according to the manufacturer's guidelines. A computer-assisted testing apparatus was constructed that allowed each knee to be tested as a function of knee flexion angle, joint load, and soft tissue integrity. Each knee served as its own control. While 45 kg of anterior force was applied to the tibia of the anterior cruciate ligament deficient knees, the Lenox Hill knee brace was able to decrease anterior translation from an average of 10 mm, to 5.7 mm, at 30 degrees of flexion when no vertical load was present. This limiting effect was lost when the medial collateral ligament was sectioned in addition to the anterior cruciate ligament or when both the medial and the lateral collateral ligaments were sectioned along with the anterior cruciate ligament. When 20 Newton-meters (Nm) of torque was applied to the femurs at 30 degrees of flexion without vertical load, the Lenox Hill knee brace limited external rotation of the tibia in all tested categories. For intact knees at 30 degrees of flexion and no vertical load, the Lenox Hill knee brace decreased external rotation from 18 degrees to 10 degrees. In the anterior cruciate ligament-sectioned knees, external rotation was decreased from an average of 20.2 degrees to 16.1 degrees. In the knees with sectioned anterior cruciate and medial collateral ligaments, the average reduction was from 21.2 degrees to 15.4 degrees.(ABSTRACT TRUNCATED AT 250 WORDS)     

Biomechanics of the tibiofemoral joint and knee braces

We investigated whether the kinematics of modern knee braces reflect the natural movement of the knee, especially with regard to the roll-glide ratio. Seven commercially available modern knee braces were analyzed in a new measuring unit with a 6-D positional registration system, which had been developed for this study. The results were compared to the theoretically postulated joint movements.All knee braces produced a roll-glide ratio different from the natural movement of the knee. Only the Townsend brace protected the anterior cruciate ligament at the beginning of the movement.Biomechanically, none of the knee braces tested provided efficient protection for the knee movement. We propose a new functional external joint, which allows restoration of the natural roll-glide mechanism of the articulating surfaces.     

The effect of ketorolac on anteroposterior knee laxity after anterior cruciate ligament reconstruction

This study investigated the effect of ketorolac on anteroposterior laxity after anterior cruciate ligament (ACL) reconstruction. A total of 168 ACL reconstructions performed between July 2003 and November 2004 were reviewed. The 6-week KT-1000 manual maximum differences between the ACL-reconstructed knee and nonoperative knee were compared for patients who received ketorolac and those who did not. Mean manual maximum difference in anterior displacement was 0.6 mm in the ketorolac group and -0.6 mm in the non-ketorolac group (P=.03). When bone-patellar tendon grafts were analyzed as a separate group, mean manual maximum difference was 0.5 mm in the ketorolac group and -1.4 mm in the non-ketorolac group (P=.007). When hamstring grafts were analyzed separately, mean manual maximum difference was 0.7 mm in the ketorolac group and 0.4 mm in the non-ketorolac group (P=.59). The use of ketorolac during bone-patellar tendon autograft ACL reconstruction was associated with increased AP laxity at 6 weeks postoperatively. Level of Evidence: Level III, retrospective comparative study.     

Using real‐time MRI to quantify altered joint kinematics in subjects with patellofemoral pain and to evaluate the effects of a patellar brace or sleeve on joint motion

Abnormal patellofemoral joint motion is a possible cause of patellofemoral pain, and patellar braces are thought to alleviate pain by restoring normal joint kinematics. We evaluated whether females with patellofemoral pain exhibit abnormal patellofemoral joint kinematics during dynamic, weight‐bearing knee extension and assessed the effects of knee braces on patellofemoral motion. Real‐time magnetic resonance (MR) images of the patellofemoral joints of 36 female volunteers (13 pain‐free controls, 23 patellofemoral pain) were acquired during weight‐bearing knee extension. Pain subjects were also imaged while wearing a patellar‐stabilizing brace and a patellar sleeve. We measured axial‐plane kinematics from the images. Females with patellofemoral pain exhibited increased lateral translation of the patella for knee flexion angles between 0°and 50° (p = 0.03), and increased lateral tilt for knee flexion angles between 0° and 20° (p = 0.04). The brace and sleeve reduced the lateral translation of the patella; however, the brace reduced lateral displacement more than the sleeve (p = 0.006). The brace reduced patellar tilt near full extension (p = 0.001), while the sleeve had no effect on patellar tilt. Our results indicate that some subjects with patellofemoral pain exhibit abnormal weight‐bearing joint kinematics and that braces may be effective in reducing patellar maltracking in these subjects. Published by Wiley Periodicals, Inc. J Orthop Res 27: 571–577, 2009     

Sense and nonsense of knee orthosis

The trend for early mobility after surgical treatment of knee joint ligament injuries has led to the production of a large number of different braces in recent years. To allow an approximation of the very complex motion of the human knee, the use of braces with so-called physiological hinges has been recommended in the last few years. The authors report on a group of 50 patients who had sustained injuries to the cruciate ligament and had received IOWA knee braces following surgical treatment, the fit being subsequently checked by X-ray. These checks clearly demonstrated that the hinge of the brace hardly coincides with the knee axes and that there were deviations ranging from 1 to 4 cm. The authors therefore come to the conclusion that brace-fit must be checked by X-ray in all cases and that incorrectly fitted braces should be corrected before use. There is so far no evidence that so-called physiological hinges are really superior to braces with single axes. The current trends and developments cannot really be justified as long as there is no guarantee that the axes of brace and human knee coincide both in motion and during weight-bearing.     

Measurement of brake response time after right anterior cruciate ligament reconstruction.

Recommendations on safe driving after anterior cruciate ligament (ACL) reconstruction have been largely intuitive. This study evaluated 12 male patients who underwent ACL reconstruction with subsequent outpatient rehabilitation and compared them with 10 subjects who had no knee dysfunction. The following clinical measures were assessed every 2 weeks for 10 weeks: brake response time (BRT), 6-meter walk time (6MWT), knee range of motion (ROM), pain (visual analog scale), and joint effusion. Statistical testing was completed using analysis of covariance with repeated measures. The results from treatment group were compared with norms from the AAA Traffic Safety and Engineering Department. BRT showed significant differences over 10 weeks (P =.043) in the study group. There were no significant differences between the study and control group based on condition (ACL reconstruction v control) (P =.586). Pain and effusion were found to have no significant interaction effect on BRT. The treatment group's BRT increased from the 25th percentile (AAA normals) to the 87th percentile after 10 weeks of rehabilitation. Although treatment group BRT was equal to AAA normal population BRT at week 4, the large improvement from week 2 to week 4 meant that learning effects could not be ruled out until week 6. Significant differences were found for 6MWT between week 2 and all other weeks (P <.0001). The results suggest brake reaction time matches control times at 4 to 6 weeks. Thus, BRT might be used to establish return to driving criteria (in part) after ACL reconstruction if other driving impediments do not exist.     

Knee Bracing

The authors present an overview of the design and functional features of knee braces and their relationship to knee biomechanics. Four types of knee braces-prophylactic, rehabilitative, functional, and patellofemoral-have been developed to cover the wide variety of indications in patients who have suffered knee injuries or hope to prevent them. Important considerations when choosing specific brace types are discussed, and summaries of relevant research are presented. Clinical criteria for brace selection are offered to help physicians and sports medicine professionals in choosing the right brace for each patient.     

改良张力支具对肱骨髁间骨折患者术后功能康复的临床效果评价

目的探讨改良张力支具对肱骨髁间骨折患者术后功能康复的临床效果评价。 方法回顾性分析本院采用切开复位内固定术治疗的40例肱骨髁间骨折患者的资料。单纯采用普通固定支具进行功能锻炼的为对照组（21例）,采用改良张力支具进行功能锻炼的为观察组（19例）。比较两组患者术后去除支具和末次随访时肘关节屈曲度、肘关节背伸度、前臂旋前度、前臂旋后度和Mayo肘关节功能评分,以评定改良张力支具的疗效。 结果所有患者术后均获得随访,平均随访13.79个月。观察组与对照组相比,术后去除支具时肘关节屈伸活动度[（104.47±12.37）° vs.（88.85±8.10）°,P<0.001],差异有统计学意义;肘关节旋转活动度[（140.31±16.87）° vs.（135.66±12.86）°,P=0.331],差异无统计学意义;肘关节Mayo评分[（78.84±5.04）分vs.（73.80±4.46）分,P=0.002],差异有统计学意义。末次随访时肘关节屈伸活动度[（107.52±12.30）° vs.（93.00±8.47）°,P<0.001],差异有统计学意义;肘关节旋转活动度[（141.42±17.02）° vs.（137.19±12.80）°,P=0.37],差异无统计学意义;肘关节Mayo评分[（80.15±5.24）分vs.（74.95±4.18）分,P=0.001],差异有统计学意义。 结论术后使用改良张力支具可以改善肱骨髁间骨折患者的屈伸活动度和肘关节功能。     

Comparison of the Effects of the Anderson Knee Stabler and McDavid Knee Guard on the Kinematics of the Lower Extremity during Gait*

* This study was completed in partial fulfillment of Ms. Van Horn's master's degree, University of North Carolina at Chapel Hill. The purpose of this study was to compare gait patterns among subjects wearing Anderson Knee Stabler braces, McDavid Knee Guards, and no braces. Fifteen male subjects were filmed while running on a treadmill at 4 mph and 8 mph without a brace, with an Anderson Knee Stabler, and with a McDavid Knee Guard. Fourteen gait variables were measured for each brace and speed condition. Analysis of the variables with multivariate ANOVA indicated that there was an increase in hip and knee flexion and knee angular velocity with and without braces at 8 mph as compared to 4 mph, a decrease in knee extension when either brace was worn, and minimal gait pattern differences with the Anderson Knee Stabler as compared with the McDavid Knee Guard (all results p < 0.05). The results of this study demonstrate that no clear superiority exists between the braces' effect on the gait characteristics measured. Therefore, other parameters should be considered when making brace selections.J Orthop Sports Phys Ther 1988;9(7):254-260.     

An in vivo analysis of the effectiveness of the osteoarthritic knee brace during heel-strike of gait.

The objective of this study was to analyze the effects of off-loading knee braces in patients diagnosed with symptomatic unicompartmental osteoarthritis. Under fluoroscopic surveillance, 15 patients were asked to perform normal gait on a treadmill. Each patient was asked initially to walk without using a knee brace and then to walk while wearing a brace. The fluoroscopic images of the patients at heel-strike were downloaded to a workstation computer. Condylar separation angle of the knee joint and the distances from the medial and lateral femoral condyles to the tibial plateau (condylar separation) were measured. Twelve of 15 patients (80%) reported relief of pain and demonstrated condylar separation of the degenerative compartment with the use of the off-loading brace. The 3 patients who did not demonstrate condylar separation were obese, making accurate brace fitting difficult. The average change in condylar separation and condylar separation angle was 1.2 mm (range, 0.0-4.5 mm) and 2.2 degrees (range, 0.0 degrees-7.8 degrees). This study demonstrated that condylar separation of a degenerative knee compartment can be achieved with off-loading braces with subsequent subjective relief of knee pain.     

To brace or not to brace? How effective are knee braces in rehabilitation?

Since the clinical benefit of knee braces has yet to be defined, discussion about braces after reconstructive surgery of the anterior cruciate ligament remains controversial. The use of prophylactic braces in sport did not prove to be effective. In ACL insufficient knee joints, the operative treatment is preferred over the use of functional knee braces. Therefore, the postoperative rehabilitation presents the main application of braces. Modern operative techniques with an initial strong fixation of the ACL graft make a functional postoperative treatment without external fixation possible. In the presented meta-analysis of the literature about knee braces, results from clinical and experimental studies are compared. No published clinical data have shown that braces have any effect on postoperative outcome after ACL-reconstruction. Also, no evidence of a significant bracing effect could be demonstrated in the experimental in vivo or in vitro studies, except a limited stabilizing function for lower shear stress below the physiological loads. Consequently, the systematic use of braces in the rehabilitation after ACL reconstruction cannot be recommended.     

Controlling anterior tibial displacement under static load: a comparison of two braces

This article presents data comparing the restraining effect of the Lenox Hill and the CTi brace to static loading using the KT-1000 Knee Ligament Arthrometer. Testing was performed at 25 degrees and 90 degrees in 15 patients with documented single ligament injuries involving the anterior cruciate. The opposite knee was determined to be normal by subjective and objective testing and was used as the control. Results showed that the anterior drawer tests, both the Lenox Hill and the CTi brace improved the ACL deficient knee significantly. With 15 lb of passive loading, both the Lenox Hill and the CTi brace improved the drawer to within normal limits. However, only the CTi brace was able to return the drawer to within the normal range at the 20 lb force level. Neither brace improved the drawer to normal when subjected to the higher loads created by an active drawer test. At 90 degrees, 15 lb of passive loading could not discriminate between the braced and the unbraced knee or between the normal and ACL deficient knee. When 20 lb of force was applied, only the CTi brace improved the drawer significantly, which placed the drawer into the normal range. Under static testing condition, the CTi brace proved to be better than the Lenox Hill in controlling the anterior drawer in flexion and at 20 lb of passive loads; however, when higher loading forces were used in the active anterior drawer test, neither brace was effective in controlling anterior tibial translation.(ABSTRACT TRUNCATED AT 250 WORDS)     

Fracture bracing the humerus.

The use of humeral fracture braces has become our preferred method of treatment for fractures of the shaft of the humerus. These braces are easy to apply and adjust; the patient's acceptance of this method of treatment is high. We compared this method of treatment with the traditional method of plaster U-slab immobilization. A group of patients treated with a plaster U-slab were matched for type and level of fracture with a group treated with a humeral fracture brace and compared with regard to fracture healing and functional outcome. There was no difference between groups for healing time and final alignment of the fracture. However, there was a greater range of elbow motion at the time of union in the fracture brace group (11 degrees-126 degrees) compared with the U-slab group (50 degrees-119 degrees P less than 0.05). These results confirmed that humeral fracture bracing permits greater functional use of the limb without affecting fracture healing and alignment.