Background: Persistent anterolateral rotatory laxity after anterior cruciate ligament (ACL) reconstruction (ACLR) has been correlated with poor clinical outcomes and graft failure. Hypothesis: We hypothesized that a single-bundle, hamstring ACLR in combination with a lateral extra-articular tenodesis (LET) would reduce the risk of ACLR failure in young, active individuals. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This is a multicenter, prospective, randomized clinical trial comparing a single-bundle, hamstring tendon ACLR with or without LET performed using a strip of iliotibial band. Patients 25 years or younger with an ACL-deficient knee were included and also had to meet at least 2 of the following 3 criteria: (1) grade 2 pivot shift or greater, (2) a desire to return to high-risk/pivoting sports, (3) and generalized ligamentous laxity (GLL). The primary outcome was ACLR clinical failure, a composite measure of rotatory laxity or a graft rupture. Secondary outcome measures included the P4 pain scale, Marx Activity Rating Scale, Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee score, and ACL Quality of Life Questionnaire. Patients were reviewed at 3, 6, 12, and 24 months postoperatively. Results: A total of 618 patients (297 males; 48%) with a mean age of 18.9 years (range, 14-25 years) were randomized. A total of 436 (87.9%) patients presented preoperatively with high-grade rotatory laxity (grade 2 pivot shift or greater), and 215 (42.1%) were diagnosed as having GLL. There were 18 patients lost to follow-up and 11 who withdrew (~5%). In the ACLR group, 120/298 (40%) patients sustained the primary outcome of clinical failure, compared with 72/291 (25%) in the ACLR+LET group (relative risk reduction [RRR], 0.38; 95% CI, 0.21-0.52; P < .0001). A total of 45 patients experienced graft rupture, 34/298 (11%) in the ACLR group compared with 11/291 (4%) in the ACL+LET group (RRR, 0.67; 95% CI, 0.36-0.83; P < .001). The number needed to treat with LET to prevent 1 patient from graft rupture was 14.3 over the first 2 postoperative years. At 3 months, patients in the ACLR group had less pain as measured by the P4 ( P = .003) and KOOS ( P = .007), with KOOS pain persisting in favor of the ACLR group to 6 months ( P = .02). No clinically important differences in patient-reported outcome measures were found between groups at other time points. The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale ( P = .11). Conclusion: The addition of LET to a single-bundle hamstring tendon autograft ACLR in young patients at high risk of failure results in a statistically significant, clinically relevant reduction in graft rupture and persistent rotatory laxity at 2 years after surgery. Registration: NCT02018354 ( ClinicalTrials.gov identifier)
Purpose: To assess the functional outcomes of patients included in the Stability Study randomized controlled trial comparing anterior cruciate ligament reconstruction (ACLR) alone with ACLR with lateral extra-articular tenodesis (LET) at 6, 12, and 24 months postoperatively. Methods: Six hundred eighteen patients undergoing ACLR, all under the age of 25 years either returning to contact pivoting sport or displaying signs of high-grade rotatory laxity or generalized ligamentous laxity, were randomly assigned to receive ACLR alone or ACLR plus LET. A total of 356 of these patients were randomized at centers participating in the functional assessments. Our primary outcome was Limb Symmetry Index, calculated using a series of 4-hop tests at 6, 12, and 24 months postoperatively. Secondary outcome measures included pain, patient-reported function, and isokinetic strength testing. Results: We found no statistically significant difference in the proportion of patients either unwilling or unfit to complete the hop testing in the ACLR alone or ACLR with LET group at 6 months (40 vs 40 respectively; P ¼ 1.00), 12 months (25 vs 27; P ¼ .76), and 24 months (21 vs 23; P ¼ .87). Of those who completed hop testing, there were no statistically significant differences between groups in Limb Symmetry Index at 6, 12, or 24 months. Self-reported function (Lower Extremity Functional Score) significantly favored the ACLR alone group at 3 (P ¼ .01) and 6 months (P ¼ .02) postoperative but was similar by 12 months postoperative. Pain scores (P4) also showed a statistically significant difference in favor of the ACL alone group, but this also resolved by 6 months. Quadriceps peak torque (P ¼ .03) and average power (P ¼ .01) were also significantly different in favor of the ACLR alone group at 6 months postoperative; however, these were similar between groups by 12 months postoperative (P ¼ .11 and
Purpose: Clinicians do not currently have a simple means of identifying patients at risk for developing incident and persisting knee symptoms in osteoarthritis (OA). We examined whether a clinically detected knee effusion predicts this. Methods: Data were extracted from the Osteoarthritis Initiative. All participants (n ¼ 4646) and the subgroup with baseline ROA (n ¼ 2249) were analysed. A bulge sign was assessed at baseline, 24 and 48 months, while a synovial fluid aspirate was performed at baseline to validate the clinical measure. Knee symptoms were assessed at baseline, 12, 24, 36, 48 and 60 months using the Western Ontario and McMaster Universities Osteoarthritis Index. Results: A clinically detected knee effusion was observed in 21.1% of people with, and 10.7% of people without, ROA. Participants with a clinically detected knee effusion had greater synovial fluid volume aspirated than those without (12.5 ml versus 6.7 ml, p < 0.001). In the total population, the presence of a clinically detected knee effusion was associated with more severe WOMAC scores (B range 0.34e2.98, 95% CI range 0.21e4.15) cross-sectionally and at each 12 month follow-up (OR range 1.22e1.34, 95% CI 1.07e1.53, all p 0.002). The presence of a clinically detected knee effusion at baseline was associated with incident pain (OR 1.61, 95% CI 1.26e2.05, p < 0.001) and poor function (OR 1.44, 95% CI 1.09e1.91, p ¼ 0.01), as well as persisting knee pain, stiffness and poor function (OR range 1.30e1.41, 95% CI 1.11e1.66, all p 0.002). Similar results were observed when those with and without ROA were examined separately. Conclusions: This is the first study to demonstrate that a clinically detected knee effusion is associated with incident and persisting knee pain. These data provide clinicians a simple method for identifying patients with knee OA most likely to develop, or have persistent pain, and who should be targeted in order to modify knee symptoms.
Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Background: Anterior cruciate ligament (ACL) reconstruction (ACLR) has higher failure rates in young active patients returning to sports as compared with older, less active individuals. Augmentation of ACLR with an anterolateral procedure has been shown to reduce failure rates; however, indications for this procedure have yet to be clearly defined. Purpose/Hypothesis: The purpose of this study was to identify predictors of ACL graft failure in high-risk patients and determine key indications for when hamstring ACLR should be augmented by a lateral extra-articular tenodesis (LET). We hypothesized that different preoperative characteristics and surgical variables may be associated with graft failure characterized by asymmetric pivot shift and graft rupture. Study Design: Case-control study; Level of evidence, 3. Methods: Data were obtained from the Stability 1 Study, a multicenter randomized controlled trial of young active patients undergoing autologous hamstring ACLR with or without a LET. We performed 2 multivariable logistic regression analyses, with asymmetric pivot shift and graft rupture as the dependent variables. The following were included as predictors: LET, age, sex, graft diameter, tear chronicity, preoperative high-grade knee laxity, preoperative hyperextension on the contralateral side, medial meniscal repair/excision, lateral meniscal repair/excision, posterior tibial slope angle, and return-to-sports exposure time and level. Results: Of the 618 patients in the Stability 1 Study, 568 with a mean age of 18.8 years (292 female; 51.4%) were included in this analysis. Asymmetric pivot shift occurred in 152 (26.8%) and graft rupture in 43 (7.6%). The addition of a LET (odds ratio [OR], 0.56; 95% CI, 0.37-0.83) and increased graft diameter (OR, 0.62; 95% CI, 0.44-0.87) were significantly associated with lower odds of asymmetric pivot shift. The addition of a LET (OR, 0.40; 95% CI, 0.18-0.91) and older age (OR, 0.83; 95% CI, 0.72-0.96) significantly reduced the odds of graft rupture, while greater tibial slope (OR, 1.15; 95% CI, 1.01-1.32), preoperative high-grade knee laxity (OR, 3.27; 95% CI, 1.45-7.41), and greater exposure time to sport (ie, earlier return to sport) (OR, 1.18; 95% CI, 1.08-1.29) were significantly associated with greater odds of rupture. Conclusion: The addition of a LET and larger graft diameter were significantly associated with reduced odds of asymmetric pivot shift. Adding a LET was protective of graft rupture, while younger age, greater posterior tibial slope, high-grade knee laxity, and earlier return to sport were associated with increased odds of graft rupture. Orthopaedic surgeons should consider supplementing hamstring autograft ACLR with a LET in young active patients with morphological characteristics that make them at high risk of reinjury.
Background The purpose of anterior cruciate ligament reconstruction (ACLR) is to restore stability to the knee. Persistent rotational laxity following ACLR has been correlated with poor outcome and graft failure. We hypothesize that anterolateral complex reconstruction by way of a Modified Lemaire Lateral Extra-articular Tenodesis (LET) in combination with single bundle ACLR would reduce the risk of persistent rotatory laxity in young individuals who are deemed as being at high risk of failure. We will conduct a pragmatic, multicenter, randomized clinical trial comparing standard single bundle hamstring ACLR with combined ACLR and LET. Methods Six-hundred patients (300 per group) aged 25 years or less with an ACL deficient knee that meet two of the following three criteria will be included: 1) Grade 2 pivot shift or greater; 2) Returning to high risk cutting or pivoting sports; 3) Generalized ligamentous laxity. Participants will be seen at 3-months, 6-months, 12-months and 24-months post-operatively. The primary outcome measure is graft failure requiring revision ACLR or symptomatic instability associated with a positive asymmetric pivot shift indicating persistent rotational laxity. Patients will complete secondary outcome measures at each follow-up visit including patient-reported outcome measures, functional and biomechanical testing, and magnetic resonance imaging. Discussion This protocol is the first adequately powered randomized clinical trial investigating the effects of augmenting ACLR with an LET in patients at high-risk of graft failure. The successful completion of this trial has the potential to change surgical practice and provide evidence for the role of the LET in ACLR. Trial registration The trial is registered at ClinicalTrials.gov: NCT02018354 , 23-12-2013.
PurposeThe purpose of this study was to analyse adverse events encountered in medial opening wedge high tibial osteotomy (MOWHTO) utilizing contemporary surgical techniques with the Tomofix locking plate (DePuy Synthes, Raynham, MA, USA) and categorize them by their severity and need for further medical/surgical management. It was hypothesized that there would be low rates of serious complications after medial opening wedge high tibial osteotomy utilizing an internal locking plate fixator. MethodsThis study included 169 consecutive patients (200 knees) who underwent MOWHTO with a Tomofix locking plate at a single center, completing a minimum 2‐year follow‐up. Types of intra‐ and post‐operative adverse events were retrospectively identified by an independent observer and categorized by their severity and further need of management. Additional surgery due to elective hardware removal was not included in the adverse event classification. ResultsThere were in total 58 (29%) adverse events, the majority (13.5%) of which required no additional treatment (class 1). Class 1 events included lateral cortex hinge fractures that were observed in 8.5% (17 knees) and delayed wound healing 2% (4/200). Adverse events requiring additional or extended nonoperative management (class 2) were 9%. These included post‐operative stiffness in 1% (2/200), low grade infection in 1.5% (3/200), delayed union in 5.4% (11/200), deep vein thrombosis 0.5% (1/200). One hundred and four knees (52%) underwent elective hardware removal. Serious adverse events requiring unplanned additional or revision surgery and/or long‐term medical care (class 3) were the least reported (6.5%). Aseptic non‐union was reported in 2.5%, deep infection requiring revision in 2% and limited hardware failure 1%. ConclusionA low rate of serious complications (6.5%) requiring unplanned additional surgery (class 3) was found. The overall rate of complications following MOWHTO with Tomofix locking plate was 29% and the majority (13.5%) required no additional treatment (class 1). Lateral hinge fractures were the most common complication (8.5%) and these were associated with corrections over 12 mm. However, 52% knees required a further operation for elective hardware removal. Level of evidenceLevel IV, prospective study without control group.
Background: Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults. Purpose: To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol–5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months. Results: At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, –7.22 to 7.45]; P = .98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, –5.03 [95% CI, −10.40 to −0.03]; P = .049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89]; P = .026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%). Conclusion: Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group. Registration: NCT01623843 ( ClinicalTrials.gov identifier)
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