Collagen versus gelatin-coated Dacron versus stretch polytetrafluoroethylene in abdominal aortic bifurcation graft surgery: results of a seven-year prospective, randomized multicenter trial

BACKGROUND: A prospective randomized multicenter trial was performed to compare knitted gelatin-coated Dacron bifurcation grafts, knitted collagen-coated Dacron grafts, and stretch polytetrafluoroethylene (PTFE) grafts. METHODS: Between 1991 and 1998, 315 elective patients were randomized by age, gender, diabetes, runoff, indication (aneurysm, aortoiliac occlusive disease), and nicotine consumption at 3 centers of vascular surgery in Austria. The patients received gelatin-coated Dacron (GEL-D) grafts (n = 109), collagen-coated Dacron (COL-D) grafts (n = 100), or stretch PTFE grafts (n = 106). RESULTS: No intraoperative deaths occurred. The 30-day mortality was 3%. No difference was found between the 3 graft materials in long-term patency. The primary 5-year patency rates were 92% for GEL-D, 89% for COL-D, and 91% for stretch PTFE (P =.6001). The secondary 5-year patency rates also differed: 97% for GEL-D, 100% for COL-D, and 97% for stretch PTFE (P =.2062). Early occlusions were observed overall in 3% and late occlusions in 5% of patients. When both Dacron grafts were compared collectively with stretch PTFE, a difference was found in infection rate: Dacron 3% (6/209) versus PTFE 0% (0/106); P <.03. CONCLUSIONS: The bifurcation grafts of all 3 materials were comparable in primary and secondary patency rates, incidence of false aneurysms, and rate of perioperative complications. Graft infections were confined to the 2 Dacron grafts and did not occur in stretch PTFE grafts.     

Dacron versus polytetrafluoroethylene for Y-aortic bifurcation grafts: a six-year prospective, randomized trial.

BACKGROUND. A prospective, randomized trial was conducted to compare Dacron with expanded polytetrafluoroethylene (ePTFE) in reconstructive aortoiliac surgery. No comparable trial with a prospective, randomized design with a comparable number of patients or an equal long-term follow-up period can be found in the literature. METHODS. Between 1984 and 1989, 165 patients were randomized for either Dacron or ePTFE on the basis of age, sex, indication for surgery, diabetes, nicotine consumption, runoff, and operative approach. The two groups were well matched for randomization criteria, as well as the incidence of aneurysms. RESULTS. No statistically significant difference was found between the two graft materials in terms of patency rates (corrected 3-year patency rates: Dacron = 95% vs ePTFE = 95%; Breslow, p = 0.83; Mantel-Cox, p = 0.74). Subgroup analysis comparing long-term patency rates of the two graft materials and relating them to poor runoff, good runoff, aneurysms, and arterial occlusive disease also failed to show any significant differences between ePTFE and Dacron. Early graft failure (n = 6; 3.6% of the patient population; p = 0.045) and severe abdominal graft infection (n = 3; 1.8% of the total population) were seen only in ePTFE grafts. However, these did not affect the corrected long-term patency rate of ePTFE grafts. There were five late graft failures with PTFE (3.0%) and four with Dacron (2.4%). CONCLUSIONS. Graft materials currently available for aortoiliac repair were comparable in terms of corrected long-term patency rates. The alleged advantages of PTFE were not confirmed by our data. PTFE grafts were associated with a higher rate of complications, and more redo operations were required to duplicate the results obtained with Dacron.     

Aorto-Y-bifurcation graft: Dacron versus PTFE. Preliminary results of a randomized prospective study

A randomized prospective study comparing PTFE-Y and Dacron-Y-grafts with regard to function rate, morphology, hemodynamic differences along the proximal anastomosis and body of the graft, complications and quality of material was performed. Between March 1983 and February 1987, 112 patients were admitted to the study. Randomization including the criteria of age, sex, indication to operation (chronic occlusive disease, aneurysm) run-off, diabetes, nicotine consumption and operative approach (transperitoneal, retroextraperitoneal) followed the methods of adaptive randomization developed by Pocock and Simon and was well balanced. Function rate and complications as well as morphological alterations showed no significant differences in either group. During a mean observation period of 24 months, Group I yielded a 97% and Group II a 95% function rate (Kaplan-Meier). In all patients but one in each group with limb graft occlusions (n = 5) function was regained by successful thrombectomy and profundaplasty. With respect to Doppler ultrasound differences in flow pattern, in four patients with enlarged proximal side-end anastomosis and adequate--not to large--incision is recommended performing the proximal anastomosis.     

Heparin-bonded Dacron or polytetrafluorethylene for femoropopliteal bypass: five-year results of a prospective randomized multicenter clinical trial

OBJECTIVE: Dacron was largely abandoned for femoropopliteal bypass 30 years ago, because better patency rates were achieved with saphenous vein. Despite the range of potential prosthetics, polytetrafluoroethylne (PTFE) clearly predominates in current femoropopliteal practice. We compared heparin-bonded Dacron (HBD) with PTFE in a randomized multicenter clinical trial. METHOD: Over 28 months, 209 patients (179 above-knee disease, 30 below-knee disease) were randomized to receive HBD (n = 106) or PTFE (n = 103) grafts. Aspirin, 300 mg/d, was started before surgery, and was continued if tolerated. RESULTS: At follow-up for a minimum of 5 years (mean, 76 months; range, 60-89 months), 37 patients (17.7%) had died with patent grafts and 121 (58%) grafts were occluded. Primary patency rate, measured with Kaplan-Meier survival analysis, was 46% (95% confidence interval [CI], 35%-57%) at year 5 for HBD, compared with 35% for PTFE (CI, 25%-45%; P < .055). Long-term patency was achieved in only 4 of 78 interventions performed in 55 thrombosed grafts. Secondary patency rate for HBD was 47% (CI, 36%-58%), and for PTFE was 36% (CI, 26%-46%). Risk factors for arterial disease did not significantly influence prosthetic patency. Major limb amputation was necessary in 9 patients with HBD grafts and 20 patients with PTFE grafts (P < .025). Two amputations in the HBD group and 8 amputations in the PTFE group were in patients undergoing bypass surgery to treat claudication only. Limb salvage rate was 86% (CI, 77%-95%) and 74% (CI, 64%-84%), respectively. CONCLUSIONS: Significantly better patency rates were achieved with HBD than with PTFE at 3 years (P < .044), but the difference was no longer statistically significant at 5 years (P < .055). The incidence of major limb amputation, however, was significantly greater (P < .025) in the PTFE group compared with the HBD group at both 3 and 5 years of follow-up.     

Laparoscopic versus open sigmoid resection for diverticulitis: long-term results of a prospective, randomized trial

Background  

Elective laparoscopic sigmoid resection for diverticulitis has proven short-term benefits, but little data are available from prospective randomized trials regarding long-term outcome, quality of life, and functional results.     

Eversion versus conventional carotid endarterectomy: Late results of a prospective multicenter randomized trial

Objective: The durability of carotid endarterectomy (CEA) may be affected by carotid restenosis. The data from randomized trials show that the highest incidence of restenosis after CEA occurs from 12 to 18 months after surgery. The optimal CEA technique to reduce perioperative complications and restenosis rates is still undefined. This study examines the long-term clinical outcome and incidence of recurrent stenosis in patients who undergo eversion CEA. Previously published perioperative results of this study did not show statistically significant differences in study endpoints between the eversion and standard techniques. Methods: From October 1994 to March 1997, 1353 patients with surgical indications for carotid stenosis were randomly assigned to undergo eversion (n = 678) or standard CEA (n = 675; primary closure, 419; patch, 256). Withdrawal from the assigned treatment occurred in 1.6% of the patients (in 13 assigned to eversion CEA, and in nine assigned to standard CEA). The clinical and duplex scan follow-up examination was 99% complete, and the mean follow-up interval was 33 months (range, 12 to 55 months). The primary outcomes were perioperative and late major stroke and death, carotid restenosis (stenosis ≥ 50% of the lumen diameter detected at duplex scanning), and carotid occlusion. The primary evaluation of study outcomes was conducted on the basis of an intention-to-treat analysis. Results: Restenosis was found at duplex scanning in 56 patients (19 in the eversion group, and 37 in the standard group). Within the standard group, the restenosis rates were 7.9% in the primary closure population and 1.5% in the patched population. Of the patients with restenosis, 36% underwent cerebral angiography that confirmed restenosis in all cases. The cumulative restenosis risk at 4 years was significantly lower in the group that underwent treatment with eversion CEA as compared with the standard group (3.6% vs 9.2%; P = .01), with an absolute risk reduction of 5.6% and a relative risk reduction of 62%. Eighteen patients would have had to undergo treatment with eversion CEA to prevent one restenosis during the 4-year period. The incidence rate of ipsilateral stroke was 3.3% in the eversion population and 2.2% in the standard group. There were no significant differences in the cumulative risks of ipsilateral stroke (3.9% for eversion, and 2.2% for standard; P = .2) and death (13.1% for eversion, and 12.7% for standard; P = .7)) in the two groups. Of the 18 variables that were examined for their influence on restenosis, eversion CEA (hazard ratio, 0.3; 95% confidence interval, 0.2 to 0.6; P = .0004) and patch CEA (hazard ratio, 0.2; 95% confidence interval, 0.07 to 0.6; P = .002) were negative independent predictors of restenosis with multivariate Cox proportional hazards regression analysis. Conclusion: The EVEREST (EVERsion carotid Endarterectomy versus Standard Trial) showed that eversion CEA is safe, effective, and durable. No statistically significant differences were found in late outcome between the eversion and standard techniques at the available follow-up examination. (J Vasc Surg 2000;31:19-30.)     

In situ versus reversed femoropopliteal vein grafts: long-term follow-up of a prospective, randomized trial.

In a prospective, randomized trial, 226 patients undergoing femoropopliteal bypass for lower limb ischaemia were allocated to reversed (123 patients) or in situ (103) techniques. The groups were comparable for age, sex, incidence of diabetes, and indications for surgery. Eleven veins were rejected at operation, nine in the reversed group and two in the in situ group, leaving 114 reversed and 101 in situ grafts for study. Cumulative patency rates were not significantly different between reversed and in situ grafts at any time up to 6 years after operation, with primary patency rates at 1, 3 and 5 years of 84.8, 69.5 and 62.4 per cent for reversed grafts and 79.9, 71.2 and 63.5 per cent for in situ grafts. Small vein grafts (< 4 mm in diameter) were associated with patency rates at 1, 3 and 5 years of 63.5, 46.7 and 36.0 per cent compared with 93.9, 82.5 and 75.9 per cent for vein grafts > or = 4 mm in diameter (P < 0.002, log rank test). The patency rates of small veins employed in situ and reversed were similar. The in situ technique confers neither short- nor long-term advantage over reversed vein grafting for femoropopliteal bypass.     

Long-term results of a multicenter randomized study on direct versus crossover bypass for unilateral iliac artery occlusive disease

OBJECTIVE: To compare late patency after direct and crossover bypass in good-risk patients with unilateral iliac occlusive disease not amenable to angioplasty. METHODS: Between May 1986 and March 1991, 143 patients with unilateral iliac artery occlusive disease and disabling claudication were randomized into two surgical treatment groups, ie, crossover bypass (n = 74) or direct bypass (n = 69). The size of the patient population was calculated to allow detection of a possible 20% difference in patency in favor of direct bypass with a one-sided alpha risk of 0.05 and a beta risk of 0.10. Patients underwent yearly follow-up examinations using color flow duplex scanning with ankle-brachial systolic pressure index measurement. Digital angiography was performed if hemodynamic abnormalities were noted. Median follow-up was 7.4 years. Primary endpoints were primary patency and assisted primary patency estimated by the Kaplan-Meier method with 95% confidence interval. Secondary endpoints were secondary patency and postoperative mortality and morbidity. RESULTS: Cardiovascular risk factors, preoperative symptoms, iliac lesions TASC class (C in 87 [61%] patients and D in 56 [39%] patients), and superficial femoral artery (SFA) run-off were comparable in the two treatment groups. One patient in the direct bypass group died postoperatively. Primary patency at 5 years was higher in the direct bypass group than in the crossover bypass group (92.7 +/- 6.1% vs 73.2 +/- 10%, P = .001). Assisted primary patency and secondary patency at 5 years were also higher after direct bypass than crossover bypass (92.7 +/- 6.1% vs 84.3 +/- 8.5%, P = .04 and 97.0 +/- 3.0% vs 89.8 +/- 7.1%, P = .03, respectively). Patency at 5 years after crossover bypass was significantly higher in patients presenting no or low-grade SFA stenosis than in patients presenting high-grade (> or =50%) stenosis or occlusion of the SFA (74.0 +/- 12% vs 62.5 +/- 19%, P = .04). In both treatment groups, patency was comparable using polytetrafluoroethylene (PTFE) and polyester grafts. Overall survival was 59.5 +/- 12% at 10 years. CONCLUSION: This study showed that late patency was higher after direct bypass than crossover bypass in good-risk patients with unilateral iliac occlusive disease not amenable to angioplasty. Crossover bypass should be reserved for high-risk patients with unilateral iliac occlusion not amenable to percutaneous recanalization.     

Unilateral iliac artery occlusive disease: A randomized multicenter trial examining direct revascularization versus crossover bypass

This randomized trial compared the patency of direct unilateral aorto- or iliofemoral prosthetic bypass with that of crossover femorofemoral or iliofemoral bypass in unilateral atheromatous occlusive disease of the iliac artery. Between May 1986 and March 1991, 143 patients were enrolled in this study (74 crossover and 69 direct revascularizations). Cardiovascular risk factors, preoperative symptoms, and atheromatous lesions were similar in both groups. Patients were followed by Duplex scanning with systolic pressure index measurements. Routine digital subtraction arteriograms were obtained postoperatively and separately, when hemodynamic anomalies developed. Mean follow-up was 22 months. One patient with direct revascularization died postoperatively. Primary patency of direct revascularizations was 89.8% at 48 months compared with 52% for crossover bypass. This difference was statistically significant. Secondary patency of direct and crossover revascularization at 48 months was 92.9% and 93.6%, respectively (not significant). Even though crossover bypasses seem attractive because of their technical simplicity and low morbidity, our results suggest that direct revascularizations are preferable in the young patient with no major operative risks, while crossover bypasses remain indicated in patients at risk.Presented at the Annual Meeting of the Société de Chirurgie Vasculaire de Langue Française, June 20–21 1991, Marseille, France.     

Conservative versus surgical treatment of venous leg ulcers: a prospective, randomized, multicenter trial

BACKGROUND: The prevalence of venous leg ulcers is as high as 1% to 1.5%, and the total costs of this disease are 1% of the total annual health care budget in Western European countries. Treatment modalities are conservative or surgical. Subfascial endoscopic perforating vein surgery (SEPS) combined with superficial vein ligation is performed in many centers to address vein incompetence in patients with chronic venous leg ulcers. Several reports describe good healing and low recurrence rates, although a randomized trial to compare surgical treatment including SEPS and treatment of the superficial venous system to conservative modalities has never been performed. Therefore, a prospective, randomized, multicenter trial was conducted to study whether ambulatory compression therapy with venous surgery is a better treatment than just ambulatory compression therapy in venous leg ulcer patients. METHODS: Patients with an active (open) venous leg ulcer (CEAP C6) qualified for the study. The study consisted of two treatment groups. All patients were treated by standardized ambulatory compression therapy, and half of the patients received SEPS. Concomitant superficial venous incompetence was also treated in the second group. For allocation to both treatment groups, each patient was assigned by a computer program at the randomization center. The primary goal of the study was to compare the ulcer-free period during follow-up in both study groups. Secondary end points were ulcer healing and recurrence rates. RESULTS: From April 1997 until January 2001, 200 ulcerated legs (170 patients) were included in the study in 12 centers in The Netherlands. A total of 97 ulcers were allocated to the surgical group and 103 to the conservative group. Patient characteristics were similar in the two treatment groups at baseline, with the exception of a higher proportion in the conservative group of diabetes mellitus. Healing rates were 83% in the surgical group and 73% in the conservative group (not significant; median time to healing, 27 months). Recurrence rates were the same in both treatment groups (22% surgical vs 23% conservative). During follow-up of a mean of 29 months (median, 27 months) in the surgical group and 26 months (median, 24 months) in the conservative group, we found that in the surgical group, the ulcer-free rate was 72%, whereas in the conservative group this rate was 53% (P = .11; Mann-Whitney test). Patients with recurrent ulceration or medially located ulcers in the surgical group had a longer ulcer-free period than those treated in the conservative group (P = .02 for both). A first-time ulcer and one of the centers also had a positive effect on the ulcer-free period during follow-up (P < .001 and P = .02), independent of the treatment group. Deep vein incompetence did not affect the ulcer-free period. CONCLUSIONS: In conclusion, we suggest that patients with medial and/or recurrent ulceration should receive surgery combined with ambulatory compression therapy. A dedicated center should provide care for those patients.     

Recurrence and complications after laparoscopic versus open inguinal hernia repair: results of a prospective randomized multicenter trial

BACKGROUND: The aim of this prospective randomized multicenter trial was to evaluate the recurrence rates and complications of open versus laparoscopic repairs of inguinal hernias. METHODS: Patients with primary unilateral inguinal hernias were randomized to Shouldice repair, Bassini operation, tension-free hernioplasty (Lichtenstein repair), laparoscopic transabdominal extraperitoneal hernioplasty (TEP), or laparoscopic transabdominal preperitoneal hernioplasty (TAPP). The primary outcome parameter was the rate of recurrence at 3 years. The secondary outcome was the rate of intraoperative, perioperative, and long-term complications. Follow-up comprised of clinical examination after 1, 2, and 3 years. RESULTS: Three hundred and sixty-five patients were randomly assigned to one of the five procedures. The intention-to-treat analysis showed that the cumulative 3-year recurrence rate was 3.4% in the Bassini group, 4.7% in the Shouldice group, 0% in the Lichtenstein group, 4.7% in the TAPP group, and 5.9% in the TEP group (p = 0.48). Comparing open (Bassini, Shouldice, Lichtenstein) versus laparoscopic (TAPP, TEP) techniques (p = 0.29) and comparing the use of mesh prostheses (Lichtenstein, TAPP, TEP) versus suturing techniques (Bassini, Shouldice) (p = 0.74) showed no significance in the rate of recurrence. The rates of intraoperative (p = 0.15), perioperative (p = 0.09), and long-term complications (p = 0.13) were without significance between the five groups. Comparing mesh techniques (Lichtenstein, TAPP, TEP) versus suturing techniques (Bassini, Shouldice) showed no significance in the rate of complications. The per-protocol analysis for the comparison of mesh (Lichtenstein, TAPP, TEP) versus suturing (Bassini, Shouldice) techniques revealed that recurrences (p = 0.74), intraoperative (p = 0.64), perioperative (p = 0.27), and long-term complications (p = 0.91) were evenly distributed. CONCLUSIONS: In this multicenter study, no significant difference in the recurrence rate and complications between laparoscopic and open methods of hernia repair was revealed.     

Stapled vs excision hemorrhoidectomy: long-term results of a prospective randomized trial

HYPOTHESIS: Stapled hemorrhoidectomy offers several advantages over excision hemorrhoidectomy, including reduced postoperative pain, a reduced hospital stay, and an earlier recovery time. Furthermore, stapled hemorrhoidectomy is associated with lower hemorrhoidal recurrence on long-term follow-up. DESIGN: A randomized prospective trial. Patients were blinded to the operation technique used. Follow-up occurred at 1 and 3 weeks and 12 months postoperatively. SETTING: A university hospital providing primary, secondary, and tertiary care. PATIENTS: Forty patients with second- and third-degree hemorrhoid disease were randomized to undergo either stapled or excision hemorrhoidectomy. Two patients were excluded. All patients were subject to a follow-up examination. INTERVENTIONS: Stapled hemorrhoidectomy (Longo technique) vs excision hemorrhoidectomy (Ferguson technique). MAIN OUTCOME MEASURES: Operating time, postoperative pain (measured by the visual analog scale), hospital stay, histologic features, morbidity, defecation habit, continence, recovery time (return to work), and hemorrhoid recurrence at 1 year. RESULTS: Stapled vs excision hemorrhoidectomy was associated with a significantly reduced operating time (30 vs 43.25 minutes; P<.001), reduced postoperative pain scores (visual analog score) on the first 4 postoperative days (day 1: 2.7 vs 6.3; day 2: 1.7 vs 6.3; day 3: 0.8 vs 5.4; and day 4: 0.5 vs 4.8, where 0 indicates no pain, and 10, maximum pain; P < or = .001), and an earlier return to work (6.7 vs 20.7 days;P =.001). There were no differences for stapled vs excision hemorrhoidectomy in length of hospital stay (2.4 vs 2.1 days), complications (3 [15%] of 20 patients vs 5 [25%] of 20 patients), and recurrence rate (1 [5%] of 20 patients vs 1 [5%] of 20 patients). CONCLUSIONS: Stapled hemorrhoidectomy is associated with reduced postoperative pain, earlier recovery time and return to work, and a similar recurrence rate compared with the excision technique. Provided further clinical trials confirm these findings, stapled hemorrhoidectomy may become a future gold standard.     

Retrojugular versus ventrojugular approach to carotid bifurcation for eversion endarterectomy: a prospective randomized trial.

OBJECTIVES: The aim of this prospective randomized study was to demonstrate the comparability of retrojugular access for carotid eversion endarterectomy compared to the conventional ventrojugular procedure. PATIENTS AND METHODS: Due to the expected minor and major complication rate of 5% in patients undergoing carotid surgery, a patient cohort of 600 study patients was planned. All patients underwent standard preoperative and postoperative assessment including clinical investigation and fiberoptic laryngoscopy. The 6 month follow-up examination included an evaluation of patient contentment, a duplex scan, clinical investigation and a fiberoptic laryngoscopy. RESULTS: After the first interim evaluation of 101 patients, the study was stopped because of a significant increase in temporary ipsilateral vocal cord motility dysfunction in the retrojugular access group (31% vs. 6%, p=0.0014). This early postoperative impairment was, however, not statistically significant at the follow-up examination at 6 months (2.4% vs. 0%). No other significant differences concerning major complications (death or stroke), other cranial nerve injuries, wound healing, or patient satisfaction was observed neither in the early postoperative phase nor at follow up. CONCLUSION: Due to the high incidence of temporary ipsilateral vocal cord dysfunction in patients undergoing retrojugular exposure of the carotid artery, we recommend the conventional ventrojugular approach, which can be performed by incision along the anterior border of the sternomastoid muscle or by transversal skin incision.     

Mid-term results of robot-assisted laparoscopic surgery for aortoiliac occlusive disease

The aim of this study was to evaluate middle-term clinical results of robot-assisted laparoscopic surgery (RALS) to treat aortoiliac occlusive disease (AIOD). Between 2002 and 2007, 28 consecutive patients received robot-assisted laparoscopic aortobifemoral bypass grafting (n = 24) or aortoiliac endarterectomy (n = 4). Patients were followed prospectively. RALS could be completed successfully in 24 patients; conversion to open surgery was necessary in four patients (14%). Median operative time was 350 min. Median aortic clamping time was 70 min. Median hospital stay was five days. One patient died within 30 days. Non-lethal complications occurred in four patients (14%). Clinical symptoms improved in all patients. Primary and secondary limb-based patencies at 36 months were 89% and 91%, respectively. In conclusion, RALS is a feasible and durable technique for patients with AIOD. Although operative times are long, RALS allows rapid postoperative recovery.     

Chemonucleolysis versus discectomy: a randomized multicenter trial

A randomized clinical trial was carried out to compare the results of open discectomy with those of chemonucleolysis in 151 patients suffering from a disc herniation at L4-5 or L5-S1. All patients fulfilled strict entry criteria; 78 patients underwent open discectomy and 73 were subjected to chemonucleolysis. An increase in radicular pain immediately after treatment was encountered in 16 patients (22%) in the chemonucleolysis group, as compared to none in the discectomy group. The efficacy of discectomy appeared to be definitely superior to that of chemonucleolysis. Within a follow-up period of 1 year, 18 patients (25%) required open discectomy following failed chemonucleolysis; two patients (3%) in the discectomy group needed a second operation. Open discectomy following previous chemonucleolysis was successful in only 44% of cases. Comparison of the final results of the two modes of treatment 12 months after the last intervention (including second treatment) did not reveal any significant differences. The duration of the preoperative symptoms, the level of disc herniation, and the leakage of contrast medium out of the disc appeared to be of no relevance to the final outcome. The complication rates in both treatment groups were low.     

A new bioabsorbable interference screw: preliminary results of a prospective, multicenter, randomized clinical trial.

SUMMARY: A randomized clinical trial was conducted to compare a bioabsorbable polyglyconate screw (Endo-Fix; Smith & Nephew, Andover, MA) to a metal screw in anterior cruciate ligament reconstruction. A total of 124 patients were operated on and 113 assessed up to 1 year postoperatively. Assessments included a history and physical examination, the IKDC evaluation, and knee arthrometry measurements. No significant differences were found between the groups with respect to any of the IKDC problem areas at 1 year. The IKDC final evaluation was normal or nearly normal in 92% of polyglyconate patients and 90% of controls. The incidence of postoperative complications was similar in the 2 groups. One polyglyconate patient developed a subcutaneous cyst that may have been related to breakdown of the screw. This resolved without treatment and the patient had an excellent clinical outcome. This study shows that the polyglyconate screw is an effective alternative to metal in endoscopic reconstruction of the ACL.