Why, When, and in Which Patients Nonoperative Treatment of Anterior Cruciate Ligament Injury Fails: An Exploratory Analysis of the COMPARE Trial.

BACKGROUND: The optimal treatment strategy for patients with an anterior cruciate ligament (ACL) rupture is still under debate. Different determinants of the need for a reconstruction have not been thoroughly investigated before. PURPOSE: To investigate why, when, and which patients with an ACL rupture who initially started with rehabilitation therapy required reconstructive surgery. STUDY DESIGN: Case-control study; Level of evidence, 3. METHODS: In the Conservative versus Operative Methods for Patients with ACL Rupture Evaluation (COMPARE) trial, 167 patients with an ACL rupture were randomized to early ACL reconstruction or rehabilitation therapy plus optional delayed ACL reconstruction. We conducted an exploratory analysis of a subgroup of 82 patients from this trial who were randomized to rehabilitation therapy plus optional delayed ACL reconstruction. The reasons for surgery were registered for the patients who underwent a delayed ACL reconstruction. For these patients, we used the International Knee Documentation Committee (IKDC) subjective knee form, Numeric Rating Scale for pain, and instability question from the Lysholm questionnaire before surgery. To determine between-group differences between the nonoperative treatment and delayed ACL reconstruction group, IKDC and pain scores during follow-up were determined using mixed models and adjusted for sex, age, and body mass index. RESULTS: During the 2-year follow-up of the trial, 41 of the 82 patients received a delayed ACL reconstruction after a median time of 6.4 months after inclusion (interquartile range, 3.9-10.3 months). Most reconstructions occurred between 3 and 6 months after inclusion (n = 17; 41.5%). Ninety percent of the patients (n = 37) reported knee instability concerns as a reason for surgery at the moment of planning surgery. Of these patients, 18 had an IKDC score ≤60, 29 had a pain score of ≥3, and 33 patients had knee instability concerns according to the Lysholm questionnaire before surgery. During follow-up, IKDC scores were lower and pain scores were higher in the delayed reconstruction group compared with the nonoperative treatment group. Patients in the delayed reconstruction group had a significantly younger age (27.4 vs 35.3 years; P = .001) and higher preinjury activity level compared with patients in the nonoperative treatment group. CONCLUSION: Patients who experienced instability concerns, had pain during activity, and had a low perception of their knee function had unsuccessful nonoperative treatment. Most patients received a delayed ACL reconstruction after 3 to 6 months of rehabilitation therapy. At baseline, patients who required reconstructive surgery had a younger age and higher preinjury activity level compared with patients who did not undergo reconstruction.

ACL reconstruction for all is not cost-effective after acute ACL rupture.

OBJECTIVES: To conduct a cost-utility analysis for two commonly used treatment strategies for patients after ACL rupture; early ACL reconstruction (index) versus rehabilitation plus an optional reconstruction in case of persistent instability (comparator). METHODS: Patients aged between 18 and 65 years of age with a recent ACL rupture (<2 months) were randomised between either an early ACL reconstruction (index) or a rehabilitation plus an optional reconstruction in case of persistent instability (comparator) after 3 months of rehabilitation. A cost-utility analysis was performed to compare both treatments over a 2-year follow-up. Cost-effectiveness was calculated as incremental costs per quality-adjusted life year (QALY) gained, using two perspectives: the healthcare system perspective and societal perspective. The uncertainty for costs and health effects was assessed by means of non-parametric bootstrapping. RESULTS: A total of 167 patients were included in the study, of which 85 were randomised to the early ACL reconstruction (index) group and 82 to the rehabilitation and optional reconstruction group (comparator). From the healthcare perspective it takes 48 460 € and from a societal perspective 78 179 €, to gain a QALY when performing early surgery compared with rehabilitation plus an optional reconstruction. This is unlikely to be cost-effective. CONCLUSION: Routine early ACL reconstruction (index) is not considered cost-effective as compared with rehabilitation plus optional reconstruction for a standard ACL population (comparator) given the maximum willingness to pay of 20 000 €/QALY. Early recognition of the patients that have better outcome of early ACL reconstruction might make rehabilitation and optional reconstruction even more cost-effective.

Differences in Knee Shape between ACL Injured and Non-Injured: A Matched Case-Control Study of 168 Patients.

OBJECTIVE: Anterior cruciate ligament (ACL) injury prevention programs could be more effective if we could select patients at risk for sustaining an ACL rupture. The purpose of this study is to identify radiographic shape variants of the knee between patients with and patients without an ACL rupture. METHODS: We compared the lateral and Rosenberg view X-rays of 168 prospectively followed patients with a ruptured ACL to a control group with intact ACLs, matched for gender, after knee trauma. We used statistical shape modeling software to examine knee shape and find differences in shape variants between both groups. RESULTS: In the Rosenberg view X-rays, we found five shape variants to be significantly different between patients with an ACL rupture and patients with an intact ACL but with knee trauma. Overall, patients who had ruptured their ACL had smaller, flatter intercondylar notches, a lower lateral tibia plateau, a lower medial spike of the eminence, and a smaller tibial eminence compared to control patients. CONCLUSION: Patients with an ACL rupture have smaller intercondylar notches and smaller tibial eminences in comparison to patients with an intact ACL after knee trauma.

Early surgical reconstruction versus rehabilitation with elective delayed reconstruction for patients with anterior cruciate ligament rupture: COMPARE randomised controlled trial.

OBJECTIVE: To assess whether a clinically relevant difference exists in patients' perceptions of symptoms, knee function, and ability to participate in sports over a period of two years after rupture of the anterior cruciate ligament (ACL) between two commonly used treatment regimens. DESIGN: Open labelled, multicentre, parallel randomised controlled trial (COMPARE). SETTING: Six hospitals in the Netherlands, between May 2011 and April 2016. PARTICIPANTS: Patients aged 18 to 65 with an acute rupture of the ACL, recruited from six hospitals. Patients were evaluated at three, six, nine, 12, and 24 months. INTERVENTIONS: 85 patients were randomised to early ACL reconstruction and 82 to rehabilitation followed by optional delayed ACL reconstruction after a three month period (primary non-operative treatment). MAIN OUTCOMES: Patients' perceptions of symptoms, knee function, and ability to participate in sporting activities were assessed with the International Knee Documentation Committee score (optimum score 100) at each time point over 24 months. RESULTS: Between May 2011 and April 2016, 167 patients were enrolled in the study and randomised to one of two treatments (mean age 31.3; 67 (40.%) women), and 163 (98%) completed the trial. In the rehabilitation and optional delayed ACL reconstruction group, 41 (50%) patients underwent reconstruction during follow-up. After 24 months, the early ACL reconstruction group had a significantly better (P=0.026) but not clinically relevant International Knee Documentation Committee score (84.7 v 79.4 (difference between groups 5.3, 95% confidence interval 0.6 to 9.9). After three months of follow-up, the International Knee Documentation Committee score was significantly better (P=0.002) for the rehabilitation and optional delayed ACL reconstruction group (difference between groups -9.3, -14.6 to -4.0). After nine months of follow-up, the difference in the International Knee Documentation Committee score changed in favour of the early ACL reconstruction group. After 12 months, differences between the groups were smaller. In the early ACL reconstruction group, four re-ruptures and three ruptures of the contralateral ACL occurred during follow-up versus two re-ruptures and one rupture of the contralateral ACL in the rehabilitation and optional delayed ACL reconstruction group. CONCLUSIONS: In patients with acute rupture of the ACL, those who underwent early surgical reconstruction, compared with rehabilitation followed by elective surgical reconstruction, had improved perceptions of symptoms, knee function, and ability to participate in sports at the two year follow-up. This finding was significant (P=0.026) but the clinical importance is unclear. Interpretation of the results of the study should consider that 50% of the patients randomised to the rehabilitation group did not need surgical reconstruction. TRIAL REGISTRATION: Netherlands Trial Register NL 2618.

Factors related to the need for surgical reconstruction after anterior cruciate ligament rupture: a systematic review of the literature.

STUDY DESIGN: Systematic literature review. OBJECTIVES: To summarize and evaluate research on factors predictive of progression to surgery after nonoperative treatment for an anterior cruciate ligament (ACL) rupture. BACKGROUND: Anterior cruciate ligament rupture is a common injury among young, active individuals. Surgical reconstruction is often required for patients who do not regain satisfactory knee function following nonsurgical rehabilitation. Knowledge of factors that predict the need for surgical reconstruction of the ACL would be helpful to guide the decision-making process in this population. METHODS: A search was performed for studies predicting the need for surgery after nonoperative treatment for ACL rupture in the Embase, MEDLINE (OvidSP), Web of Science, CINAHL, Cochrane Central Register of Controlled Trials, PubMed, and Google Scholar digital databases from inception to October 2013. Two reviewers independently selected the studies and performed a quality assessment. Best-evidence synthesis was used to summarize the evidence of factors predicting the need for surgical reconstruction after nonoperative treatment for an ACL rupture. RESULTS: Seven studies were included, 3 of which were of high quality. Based on these studies, neither sex (strong evidence) nor the severity of knee joint laxity (moderate evidence) can predict whether, soon after ACL injury, a patient will need ACL reconstruction following nonoperative treatment. All other factors identified in this review either had conflicting or only minimal evidence as to their level of association with the need for surgical reconstruction. Noteworthy is that 1 high-quality study reported that the spherical shape of the femoral condyle was predictive of the need for ACL reconstruction. CONCLUSION: Sex and knee joint laxity tests do not predict the need for ACL reconstruction soon after an ACL rupture. Independent validation in future research will be necessary to establish whether knee shape is a predictive factor. LEVEL OF EVIDENCE: Prognosis, level 1a-.

Computer-assisted surgery for knee ligament reconstruction.

BACKGROUND: Anterior cruciate ligament (ACL) reconstruction is one of the most frequently performed orthopaedic procedures. The most common technical cause of reconstruction failure is graft malpositioning. Computer-assisted surgery (CAS) aims to improve the accuracy of graft placement. Although posterior cruciate ligament (PCL) injury and reconstruction are far less common, PCL reconstruction has comparable difficulties relating to graft placement. This is an update of a Cochrane review first published in 2011. OBJECTIVES: To assess the effects of computer-assisted reconstruction surgery versus conventional operating techniques for ACL or PCL injuries in adults. SEARCH METHODS: For this update, we searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (from 2010 to July 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 5, 2013), MEDLINE (from 2010 to July 2013), EMBASE (from 2010 to July 2013), CINAHL (from 2010 to July 2013), article references and prospective trial registers. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and quasi-randomized controlled trials that compared CAS for ACL or PCL reconstruction versus conventional operating techniques not involving CAS. DATA COLLECTION AND ANALYSIS: Two authors independently screened search results, assessed the risk of bias in the studies and extracted data. Where appropriate, we pooled data using risk ratios (RR) or mean differences (MD), both with 95% confidence intervals (CI). MAIN RESULTS: The updated search resulted in the inclusion of one new study. This review now includes five RCTs with 366 participants. There were more female than male participants (70% were female); their ages ranged from 14 to 53 years. All trials involved ACL reconstructions performed by experienced surgeons.Assessing the studies' risk of bias was hampered by poor reporting of trial methods, and consequently several studies were judged to be 'unclear' for several types of bias. One trial presenting primary outcome data was at high risk of detection bias from lack of clinician blinding and attrition bias from an unaccounted loss to follow-up at two years.We found moderate quality evidence (three trials, 193 participants) of no clinically relevant difference between CAS and conventional surgery in International Knee Documentation Committee (IKDC) subjective scores (self-reported measure of knee function; scale of 0 to 100 where 100 was best function). Pooled data from two of these trials (120 participants) showed a small, but clinically irrelevant difference favouring CAS (MD 2.05, 95% CI -2.16 to 6.25). A third trial (73 participants) also found minimal difference in IKDC subjective scores (reported MD 0.2).We found low quality evidence (two trials, 120 participants) showing no difference between the two groups in Lysholm scores, also measured on a scale 0 to 100 where 100 is best function (MD 0.25, 95% CI -3.75 to 4.25). We found very low quality evidence (one trial, 40 participants) showing no difference between the two groups in Tegner scores. We found low quality evidence (three trials, 173 participants) showing the majority of participants in both groups were assessed as having normal or nearly normal knee function (86/87 with CAS versus 84/86 with no CAS; RR 1.01, 95% CI 0.96 to 1.06).Similarly, no differences were found for our secondary outcome measures of knee stability, loss in range of motion and tunnel placement. None of the trials reported on re-operation.No adverse post-surgical events were reported in two trials (133 participants); this outcome was not reported by the other three trials.CAS use was associated with longer operating times compared with conventional operating techniques: the mean difference in operating times reported in the studies ranged between 9 and 27 minutes. AUTHORS' CONCLUSIONS: From the available evidence, we are unable to demonstrate or refute a favourable effect of CAS for cruciate ligament reconstructions of the knee compared with conventional reconstructions. However, the currently available evidence does not indicate that CAS in knee ligament reconstruction improves outcome. There is a need for improved reporting of future studies of this technology.

Computer-assisted surgery for knee ligament reconstruction.

BACKGROUND: Anterior cruciate ligament (ACL) reconstruction is one of the most frequently performed orthopaedic procedures. The most common technical cause of reconstruction failure is graft malpositioning. Computer-assisted surgery (CAS) aims to improve the accuracy of graft placement. Although posterior cruciate ligament (PCL) injury and reconstruction are far less common, PCL reconstruction has comparable difficulties relating to graft placement. This is an update of a Cochrane review first published in 2011. OBJECTIVES: To assess the effects of computer-assisted reconstruction surgery versus conventional operating techniques for ACL or PCL injuries in adults. SEARCH METHODS: For this update, we searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (from 2010 to July 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 5, 2013), MEDLINE (from 2010 to July 2013), EMBASE (from 2010 to July 2013), CINAHL (from 2010 to July 2013), article references and prospective trial registers. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and quasi-randomized controlled trials that compared CAS for ACL or PCL reconstruction versus conventional operating techniques not involving CAS. DATA COLLECTION AND ANALYSIS: Two authors independently screened search results, assessed the risk of bias in the studies and extracted data. Where appropriate, we pooled data using risk ratios (RR) or mean differences (MD), both with 95% confidence intervals (CI). MAIN RESULTS: The updated search resulted in the inclusion of one new study. This review now includes five RCTs with 366 participants. There were more female than male participants (70% were female); their ages ranged from 14 to 53 years. All trials involved ACL reconstructions performed by experienced surgeons.Assessing the studies' risk of bias was hampered by poor reporting of trial methods, and consequently several studies were judged to be 'unclear' for several types of bias. One trial presenting primary outcome data was at high risk of detection bias from lack of clinician blinding and attrition bias from an unaccounted loss to follow-up at two years.We found moderate quality evidence (three trials, 193 participants) of no clinically relevant difference between CAS and conventional surgery in International Knee Documentation Committee (IKDC) subjective scores (self-reported measure of knee function; scale of 0 to 100 where 100 was best function). Pooled data from two of these trials (120 participants) showed a small, but clinically irrelevant difference favouring CAS (MD 2.05, 95% CI -2.16 to 6.25). A third trial (73 participants) also found minimal difference in IKDC subjective scores (reported MD 0.2).We found low quality evidence (two trials, 120 participants) showing no difference between the two groups in Lysholm scores, also measured on a scale 0 to 100 where 100 is best function (MD 0.25, 95% CI -3.75 to 4.25). We found very low quality evidence (one trial, 40 participants) showing no difference between the two groups in Tegner scores. We found low quality evidence (three trials, 173 participants) showing the majority of participants in both groups were assessed as having normal or nearly normal knee function (86/87 with CAS versus 84/86 with no CAS; RR 1.01, 95% CI 0.96 to 1.06).Similarly, no differences were found for our secondary outcome measures of knee stability, loss in range of motion and tunnel placement. None of the trials reported on re-operation.No adverse post-surgical events were reported in two trials (133 participants); this outcome was not reported by the other three trials.CAS use was associated with longer operating times compared with conventional operating techniques: the mean difference in operating times reported in the studies ranged between 9 and 27 minutes. AUTHORS' CONCLUSIONS: From the available evidence, we are unable to demonstrate or refute a favourable effect of CAS for cruciate ligament reconstructions of the knee compared with conventional reconstructions. However, the currently available evidence does not indicate that CAS in knee ligament reconstruction improves outcome. There is a need for improved reporting of future studies of this technology.