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Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial.

ABSTRACT: BACKGROUND:Anterior cruciate ligament (ACL) rupture is a common knee injury that can lead to poor quality of life, decreased activity and increased risk of secondary osteoarthritis of the knee. Management of patients with a non-acute ACL injury can include a non-surgical (rehabilitation) or surgical (reconstruction) approach. However, insufficient evidence to guide treatment selection has led to high variation in treatment choice for patients with non-acute presentation of ACL injury. The objective of the ACL SNNAP trial is to determine in patients with non-acute anterior cruciate ligament deficiency (ACLD) whether a strategy of non-surgical management (rehabilitation) (with option for later ACL reconstruction only if required) is more clinically effective and cost effective than a strategy of surgical management (reconstruction) without prior rehabilitation with all patients followed up at 18?months. METHODS:The study is a pragmatic, multi-centre, superiority, randomised controlled trial with two-arm parallel groups and 1:1 allocation. Patients with a symptomatic non-acute ACL deficient knee will be randomised to either non-surgical management (rehabilitation) or surgical management (reconstruction). We aim to recruit 320 patients from approximately 30 secondary care orthopaedic units from across the United Kingdom. Randomisation will occur using a web-based randomisation system. Blinding of patients and clinicians to treatment allocation will not be possible because of the nature of the interventions. Participants will be followed up via self-reported questionnaires at 6, 12 and 18?months. The primary outcome is the Knee injury and Osteoarthritis Outcome Score (KOOS) at 18?months post randomisation. Secondary outcomes will include a 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. DISCUSSION:At present, no evidence-based treatment of non-acute ACL deficiency exists, particularly in the NHS. Moreover, little consensus exists on the management approach for these patients. The proposed trial will address this gap in knowledge regarding the clinical and cost effectiveness of ACL treatment and inform future standards of care for this condition. TRIAL REGISTRATION:ISRCTN: 10110685. Registered on 16 November 2016. ClinicalTrials.gov: NCT02980367. Registered in December 2016.

SUBMITTER: Davies L

PROVIDER: S-EPMC7222454 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial.

Davies Loretta L Cook Jonathan J Leal Jose J Areia Carlos Morgado CM Shirkey Beverly B Jackson William W Campbell Helen H Fletcher Heidi H Carr Andrew A Barker Karen K Lamb Sarah E SE Monk Paul P O'Leary Sean S Haddad Fares F Wilson Chris C Price Andrew A Beard David D

Trials 20200514 1

<h4>Background</h4>Anterior cruciate ligament (ACL) rupture is a common knee injury that can lead to poor quality of life, decreased activity and increased risk of secondary osteoarthritis of the knee. Management of patients with a non-acute ACL injury can include a non-surgical (rehabilitation) or surgical (reconstruction) approach. However, insufficient evidence to guide treatment selection has led to high variation in treatment choice for patients with non-acute presentation of ACL injury. Th ...[more]

PMID: 32410697

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Project description:Pre- and postoperative rehabilitation are important to the management of patients with anterior cruciate ligament (ACL) reconstruction, but little attention has been given to the costs. This study evaluated the pre- and postoperative rehabilitation charges in patients with ACL reconstruction in the United States.Patients receive preoperative rehabilitation less commonly than postoperative rehabilitation.Retrospective database study.Level 4.Using the PearlDiver database, we identified patients undergoing ACL reconstruction from 2007 through 2011 using Current Procedural Terminology codes. The associated rehabilitation charges billed to insurance providers for 90 days preoperatively and 6 months postoperatively were categorized as physical therapy or as durable medical equipment (DME). The charges were examined by year and geographic region and represented as per-patient average charges (PPACs).A total of 92,179 patients were identified in the study period. The PPAC for rehabilitation was $241 during the 90-day preoperative period and $1876 for the 6-month postoperative period. Patients averaged 2 preoperative sessions for physical therapy, with 44% of patients receiving preoperative rehabilitation in contrast with an average of 17 postoperative sessions per patient in 93% of patients. Rehabilitation charges were greater postoperatively than preoperatively (P < 0.05). Preoperatively, 24% of patients received a DME, while 35% received a DME postoperatively. Preoperative rehabilitation PPACs were highest in the Northeast, followed by Midwest, South, and West (P < 0.05). There were no significant differences in postoperative rehabilitation PPACs for geographic region (P = 0.43).Preoperative rehabilitation charges were lower than postoperative charges. A patient undergoing ACL reconstruction typically received 9 times more sessions of postoperative physical therapy than preoperative.This study found that preoperative supervised rehabilitation for patients with ACL reconstruction was infrequent across the United States.

Project description:PurposeTo develop and internally validate a machine-learning algorithm to reliably predict cost after anterior cruciate ligament reconstruction (ACLR).MethodsA retrospective review of the New York State Ambulatory Surgery and Services database was performed to identify patients who underwent elective ACLR from 2015 to 2016. Features included in initial models consisted of patient characteristics (age, sex, insurance status, income, medical comorbidities as classified by the Clinical Classifications Software diagnosis code) as well as intraoperative variables (type of anesthesia and procedure-specific factors). Models were generated to predict total charges using 4 algorithms: random forest, extreme gradient boost, elastic net penalized regression, and support vector machines with radial kernels. Training was performed with 10-fold cross-validation followed by internal validation via 0.632 bootstrapping. Model discriminative performance was assessed by area under the receiver operating characteristic curve, calibration, and the Brier score. Decision curve analysis was performed to demonstrate the net benefit of using the final model in practice.ResultsIn total, 7,311 patients undergoing ambulatory ACLR were included. The random forest model demonstrated the best performance assessed via internal validation (area under the curve = 0.85), calibration, and the Brier score (0.208). Cost incurred was influenced by anesthesia type, operating room time, and number of chronic comorbidities. Decision curve analysis revealed a net benefit for use of the random forest model and the model was integrated into a web-based open-access application.ConclusionsThe random forest model predicted cost after ambulatory ACLR using a large, statewide database with good performance. The top variables found to predict increased charges were general anesthesia, operating room time, meniscal repair, self-pay insurance, patient neighborhood characteristics, and number of chronic conditions.Level of evidenceIII, retrospective cohort study.

Project description:PurposeTo establish correlations between the anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), and patellar tendon in normal pediatric knees to inform surgical planning for ACL reconstruction graft size.MethodsMagnetic resonance imaging scans of patients ages 8 to 18 years were assessed. Measurements included ACL and PCL length, thickness, and width, and ACL footprint thickness and width at the tibial insertion. Interrater reliability was assessed with a random set of 25 patients. Pearson correlation coefficients were used to assess the correlation between ACL, PCL, and patellar tendon measurements. Linear regression models were used to test whether the relationships differed by sex or age.ResultsMagnetic resonance imaging scans of 540 patients were assessed. Interrater reliability was high for all measurements except PCL thickness at midsubstance. Sample equations for estimating ACL size are as follows: ACL length = 22.61 + 1.55∗PCL origin width (R2 = 0.46; 8- to 11-year-old male patients), ACL length = 12.37 + 0.58∗PCL length + 2.29∗PCL origin thickness - 0.90∗PCL insertion width (R2 = 0.68; 8- to 11-year-old female patients), ACL midsubstance thickness = 4.95 + 0.25∗PCL midsubstance thickness + 0.04∗PCL insertion thickness - 0.08∗PCL insertion width (R2 = 0.12; 12- to 18-year-old male patients), and ACL midsubstance width = 0.57 + 0.23∗PCL midsubstance thickness + 0.07∗PCL midsubstance width + 0.16∗PCL insertion width (R2 = 0.24; 12- to 18-year-old female patients).ConclusionsWe found correlations between ACL, PCL, and patellar tendon measurements that can be used to create equations that predict ACL size in various dimensions based on PCL and patellar tendon measurements.Clinical relevanceThere is a lack of consensus on the ideal ACL graft diameter for pediatric ACL reconstruction. The findings from this study can assist orthopaedic surgeons to individualize ACL graft size for specific patients.

Dataset Information

Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial.

Publications

Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial.

Similar Datasets

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