Comparison of surgical or non-surgical management for non-acute anterior cruciate ligament injury: the ACL SNNAP RCT.

Background: Anterior cruciate ligament injury of the knee is common and leads to decreased activity and risk of secondary osteoarthritis of the knee. Management of patients with a non-acute anterior cruciate ligament injury can be non-surgical (rehabilitation) or surgical (reconstruction). However, insufficient evidence exists to guide treatment. Objective(s): To determine in patients with non-acute anterior cruciate ligament injury and symptoms of instability whether a strategy of surgical management (reconstruction) without prior rehabilitation was more clinically and cost-effective than non-surgical management (rehabilitation). Design: A pragmatic, multicentre, superiority, randomised controlled trial with two-arm parallel groups and 1:1 allocation. Due to the nature of the interventions, no blinding could be carried out. Setting: Twenty-nine NHS orthopaedic units in the United Kingdom. Participants: Participants with a symptomatic (instability) non-acute anterior cruciate ligament-injured knee. Interventions: Patients in the surgical management arm underwent surgical anterior cruciate ligament reconstruction as soon as possible and without any further rehabilitation. Patients in the rehabilitation arm attended physiotherapy sessions and only were listed for reconstructive surgery on continued instability following rehabilitation. Surgery following initial rehabilitation was an expected outcome for many patients and within protocol. Main outcome measures: The primary outcome was the Knee Injury and Osteoarthritis Outcome Score 4 at 18 months post randomisation. Secondary outcomes included return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee-specific quality of life and resource usage. Results: Three hundred and sixteen participants were recruited between February 2017 and April 2020 with 156 randomised to surgical management and 160 to rehabilitation. Forty-one per cent (n = 65) of those allocated to rehabilitation underwent subsequent reconstruction within 18 months with 38% (n = 61) completing rehabilitation and not undergoing surgery. Seventy-two per cent (n = 113) of those allocated to surgery underwent reconstruction within 18 months. Follow-up at the primary outcome time point was 78% (n = 248; surgical, n = 128; rehabilitation, n = 120). Both groups improved over time. Adjusted mean Knee Injury and Osteoarthritis Outcome Score 4 scores at 18 months had increased to 73.0 in the surgical arm and to 64.6 in the rehabilitation arm. The adjusted mean difference was 7.9 (95% confidence interval 2.5 to 13.2; p = 0.005) in favour of surgical management. The per-protocol analyses supported the intention-to-treat results, with all treatment effects favouring surgical management at a level reaching statistical significance. There was a significant difference in Tegner Activity Score at 18 months. Sixty-eight per cent (n = 65) of surgery patients did not reach their expected activity level compared to 73% (n = 63) in the rehabilitation arm. There were no differences between groups in surgical complications (n = 1 surgery, n = 2 rehab) or clinical events (n = 11 surgery, n = 12 rehab). Of surgery patients, 82.9% were satisfied compared to 68.1% of rehabilitation patients. Health economic analysis found that surgical management led to improved health-related quality of life compared to non-surgical management (0.052 quality-adjusted life-years, p = 0.177), but with higher NHS healthcare costs (£1107, p < 0.001). The incremental cost-effectiveness ratio for the surgical management programme versus rehabilitation was £19,346 per quality-adjusted life-year gained. Using £20,000-30,000 per quality-adjusted life-year thresholds, surgical management is cost-effective in the UK setting with a probability of being the most cost-effective option at 51% and 72%, respectively. Limitations: Not all surgical patients underwent reconstruction, but this did not affect trial interpretation. The adherence to physiotherapy was patchy, but the trial was designed as pragmatic. Conclusions: Surgical management (reconstruction) for non-acute anterior cruciate ligament-injured patients was superior to non-surgical management (rehabilitation). Although physiotherapy can still provide benefit, later-presenting non-acute anterior cruciate ligament-injured patients benefit more from surgical reconstruction without delaying for a prior period of rehabilitation. Future work: Confirmatory studies and those to explore the influence of fidelity and compliance will be useful. Trial registration: This trial is registered as Current Controlled Trials ISRCTN10110685; ClinicalTrials.gov Identifier: NCT02980367. Funding: This award was funded by the National Institute of Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/140/63) and is published in full in Health Technology Assessment; Vol. 28, No. 27. See the NIHR Funding and Awards website for further award information.

The study aimed to find out whether it is better to offer surgical reconstruction or rehabilitation first to patients with a more long-standing injury of their anterior cruciate ligament in their knee. This injury causes physical giving way of the knee and/or sensations of it being wobbly (instability). The instability can affect daily activities, work, sport and can lead to arthritis. There are two main treatment options for this problem: non-surgical rehabilitation (prescribed exercises and advice from physiotherapists) or an operation by a surgeon to replace the damaged ligament (anterior cruciate ligament reconstruction). Although studies have highlighted the best option for a recently injured knee, the best management was not known for patients with a long-standing injury, perhaps occurring several months previously. Because the surgery is expensive to the NHS (around £100 million per year), it was also important to look at the costs involved. We carried out a study recruiting 316 non-acute anterior cruciate ligament-injured patients from 29 different hospitals and allocated each patient to either surgery or rehabilitation as their treatment option. We measured how well they did with special function and activity scores, patient satisfaction and costs of treatment. Patients in both groups improved substantially. It was expected that some patients in the rehabilitation group would want surgery if non-surgical management was unsuccessful. Forty-one per cent of patients who initially underwent rehabilitation subsequently elected to have reconstructive surgery. Overall, the patients allocated to the surgical reconstruction group had better results in terms of knee function and stability, activity level and satisfaction with treatment than patients allocated to the non-operative rehabilitation group. There were few problems or complications with either treatment option. Although the surgery was a more expensive treatment option, it was found to be cost-effective in the UK setting. The evidence can be discussed in shared decision-making with anterior cruciate ligament-injured patients. Both strategies of management led to improvement. Although a rehabilitation strategy can be beneficial, especially for recently injured patients, it is advised that later-presenting non-acute and more long-standing anterior cruciate ligament-injured patients undergo surgical reconstruction without necessarily delaying for a period of rehabilitation.

Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial.

BACKGROUND: Anterior cruciate ligament (ACL) rupture is a common debilitating injury that can cause instability of the knee. We aimed to investigate the best management strategy between reconstructive surgery and non-surgical treatment for patients with a non-acute ACL injury and persistent symptoms of instability. METHODS: We did a pragmatic, multicentre, superiority, randomised controlled trial in 29 secondary care National Health Service orthopaedic units in the UK. Patients with symptomatic knee problems (instability) consistent with an ACL injury were eligible. We excluded patients with meniscal pathology with characteristics that indicate immediate surgery. Patients were randomly assigned (1:1) by computer to either surgery (reconstruction) or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment), stratified by site and baseline Knee Injury and Osteoarthritis Outcome Score-4 domain version (KOOS4). This management design represented normal practice. The primary outcome was KOOS4 at 18 months after randomisation. The principal analyses were intention-to-treat based, with KOOS4 results analysed using linear regression. This trial is registered with ISRCTN, ISRCTN10110685, and ClinicalTrials.gov, NCT02980367. FINDINGS: Between Feb 1, 2017, and April 12, 2020, we recruited 316 patients. 156 (49%) participants were randomly assigned to the surgical reconstruction group and 160 (51%) to the rehabilitation group. Mean KOOS4 at 18 months was 73·0 (SD 18·3) in the surgical group and 64·6 (21·6) in the rehabilitation group. The adjusted mean difference was 7·9 (95% CI 2·5-13·2; p=0·0053) in favour of surgical management. 65 (41%) of 160 patients allocated to rehabilitation underwent subsequent surgery according to protocol within 18 months. 43 (28%) of 156 patients allocated to surgery did not receive their allocated treatment. We found no differences between groups in the proportion of intervention-related complications. INTERPRETATION: Surgical reconstruction as a management strategy for patients with non-acute ACL injury with persistent symptoms of instability was clinically superior and more cost-effective in comparison with rehabilitation management. FUNDING: The UK National Institute for Health Research Health Technology Assessment Programme.

Randomized controlled trial of osteoconductive fixation screws for anterior cruciate ligament reconstruction: a comparison of the Calaxo and Milagro screws.

PURPOSE: To compare the outcome of 2 bioabsorbable screws for tibial interference fixation in anterior cruciate ligament reconstruction with reference to rate of absorption, osteoconductive properties, and clinical outcome. METHODS: Patients undergoing primary anterior cruciate ligament reconstruction with hamstring autograft in a single unit were invited to participate in this study. Patients were randomized to receive either the Calaxo screw (Smith & Nephew, Andover, MA) or Milagro screw (DePuy Mitek, Raynham, MA) for tibial fixation. Patients were reviewed with subjective and objective evaluation by use of the International Knee Documentation Committee form, Lysholm score, KT-1000 arthrometry (MEDmetric, San Diego, CA), and clinical examination. Magnetic resonance imaging was performed at 1 year and computed tomography scanning at 1 week and at 6, 12, and 24 months. RESULTS: Sixty patients agreed to participate in the study, with 32 patients randomized to the Calaxo screw and 28 to the Milagro screw for tibial fixation. There was no significant difference in subjective or objective clinical outcome between the 2 groups. At 24 months, 88% of Calaxo screws showed complete screw resorption compared with 0% of Milagro screws (P < .001). Tibial cysts were present in 88% of the Calaxo group and 7% of the Milagro group (P = .001). At 24 months, the mean volume of new bone formation for the Calaxo group was 21% of original screw volume. Ossification of the Milagro screw was unable to be accurately assessed as a result of incomplete screw resorption. CONCLUSIONS: Both screws showed similar favorable objective and subjective outcomes at 2 years. The Calaxo screw resorbed completely over a period of 6 months and was associated with a high incidence of intra-tunnel cyst formation. The Milagro screw increased in volume over a period of 6 months, followed by a gradual resorption, which was still ongoing at 2 years. Both screws were associated with tunnel widening, and neither showed evidence of significant tunnel ossification. We conclude that, despite satisfactory clinical outcomes, the addition of "osteoconductive" materials to bioabsorbable screws is not associated with bone formation at the screw site at 2 years. LEVEL OF EVIDENCE: Level I, randomized controlled trial.

Outcomes of total knee replacement after patellofemoral arthroplasty.

There is increasing interest in the use of patellofemoral joint replacements and the cohort receiving them are the youngest of any of the groups of patients undergoing a knee arthroplasty. With more contemporary prostheses, progression of arthritis in other parts of the knee joint is becoming the predominant mechanism of failure. We conducted a multicenter retrospective comparative cohort study to discover whether the outcome of total knee replacement is compromised by prior patellofemoral joint arthroplasty. A total of 21 patients with a mean age of 61 years, who were revised from a patellofemoral joint replacement to a total knee replacement, were compared with a matched cohort of patients who underwent primary total knee replacement. At a mean follow-up of 2.4 years, the primary total knee replacement cohort had significantly better Oxford Knee Scores, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function scores, pain visual analog scores, and EQ-5D scores. There was no significant difference in patient satisfaction or EQ-5D visual analog scale.Our results indicate that although the revision of a patellofemoral joint replacement to a total knee replacement is a technically straightforward procedure, the eventual outcome may be less satisfactory when compared with a primary total knee replacement.

The Durom acetabular component. a concise follow-up of early revision rates at a minimum of 2 years.

We report our experience with 143 Durom acetabular components. Our data show a survivorship of 99.2% at 5 years, (95% CI 94.8-99.9), which is not consistent with other reports in the literature of high early failure rates. The true natural history of this component is yet to unfold completely.

Survival of the anterior cruciate ligament graft and the contralateral ACL at a minimum of 15 years.

BACKGROUND: The risks for primary anterior cruciate ligament (ACL) rupture have been established. What is less well known is the risk of graft rupture after reconstruction and also the risk of a primary ACL rupture in the contralateral knee. PURPOSE: To determine the long-term survival of the ACL graft and the contralateral ACL (CACL) after reconstruction and to identify factors that increase the odds of subsequent ACL injury. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: All patients having undergone primary ACL reconstruction in 1993 or 1994 by a single surgeon in a single unit were considered. Patients were contacted to complete a subjective interview by telephone or e-mail questionnaire at a minimum of 15 years after surgery. RESULTS: A total of 755 patients met the inclusion criteria, and ACL reconstruction was performed using a single-incision endoscopic technique with either autologous bone-patellar tendon-bone graft (BPTB; n = 314) or hamstring tendon graft (HT; n = 359) and metal interference screw fixation. Of these patients, 673 (89%) completed the questionnaire; 23% had sustained either a graft rupture or CACL rupture. Expected survival of the ACL graft was 95%, 93%, 91%, and 89% at a respective 2, 5, 10, and 15 years after reconstruction. Expected survival of the CACL was 97%, 93%, 90%, and 87%, respectively. Survival of the ACL graft was less favorable in men than in women (P = .007); ACL graft survival was not significantly different between the HT (88%) or BPTB (91%) groups (P = .149). Rupture of the CACL occurred twice as frequently as graft rupture in the BPTB group (graft survival, 84% vs 89%; P = .003). A positive family history of ACL rupture doubled the odds of both ACL graft and CACL rupture. The mean International Knee Documentation Committee subjective score at 15 years was 85. Return to preinjury sport levels was reported in 73% of patients, and 51% were still participating in strenuous or very strenuous activities at 15 years. CONCLUSION: Fifteen years after ACL reconstruction, expected survival of the ACL graft was 89% and expected survival of the CACL was 86%. Graft choice did not affect ACL graft rupture, but using BPTB increased the risk of CACL rupture compared with HT. Men had a less favorable survival rate of the ACL graft than did women, and a family history of ACL rupture increased the risk of both ACL graft and CACL rupture.

Clinic-based nerve conduction studies reduce time to surgery and are cost effective: a comparison with formal electrophysiological testing.

INTRODUCTION: Carpal tunnel syndrome is the most common compression neuropathy affecting the upper limb. Clinical diagnosis is not always clear and electrophysiological testing can be indicated when considering a patient for decompression surgery. The downside of electrophysiological testing is cost and increased time to surgery. Newer methods of performing nerve conduction studies in clinic have become available. MATERIALS AND METHODS: We investigated the use of a clinic-based, handheld, non-invasive electrophysiological device (NC-stat®) in 71 patients with suspected carpal tunnel syndrome presenting to our hand clinic in a district general hospital. We compared this to a similar cohort of 71 age-matched patients also presenting to our unit in whom formal nerve conduction studies were performed at a local neurophysiology unit. Our outcome measures were time from presentation to carpal tunnel decompression, the cost of each pathway and the practicalities of using the device in a busy hand unit. RESULTS AND CONCLUSIONS: The NC-stat® proved to be a successful device when compared with referring patients out for more formal nerve conduction studies, shortening the time from presentation to surgery from 198 days to 102 days (p<0.0001). It was also cost effective with a calculated saving to the hospital of more than £70 per patient. The device is easy to use and acceptable to patients and no adverse effects were noted.

Arthroscopically induced posterior capsular fibrosis to correct symptomatic hyperextension of the knee.

We present a technical note on 2 patients with post-traumatic symptomatic hyperextension of the knee treated with a new arthroscopic technique. Both patients were of similar ages with similar injuries resulting in an excess of hyperextension at the knee with resulting instability and pain. Both patients had not improved with a variety of nonoperative measures and 1 attempt each at simple arthroscopic debridement of the damaged tissue. Our technique involves carefully scarring the damaged posterior capsule arthroscopically, followed by extension block bracing for 12 weeks. In 2 patients who had not improved with previously described techniques, we achieved a correction of the excess hyperextension with resulting improvement in their symptoms. Two years after surgery, both patients had significantly improved Lysholm and Tegner activity scores and had returned to work. We believe this technique to be reliable and reproducible.