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Table 4 Body of Evidence Matrix

From: Anterior cruciate ligament repair with LARS (ligament advanced reinforcement system): a systematic review

Component Grade Comments
Evidence Base D-poor Level IV studies, or level I to III studies with high risk of bias • Four studies • Study design: Randomized Controlled Trial (n = 1), non-randomized, experimental trial (n = 1), case series (n = 2) • Moderate quality of evidence (refer to quality scores in text) • 319 participants across four studies. No study justified sample size or performed a power calculation
Consistency D-poor Evidence is inconsistent • Multiple study designs • Predominantly chronic populations • Differing inclusion criteria in respect to associated pathologies and injury history • Statistical analysis adequate in two out of four studies • Primary outcome measures were abbreviated or modified in two studies27, 29 potentially affecting the reliability and validity of these results.
Clinical Impact D-poor Slight or restricted • Effect sizes could not be calculated due to insufficient data reporting • Post operative laxity: Inconsistent findings • Post operative rehabilitation: Protocol adequately described in one study28, and omitted in two27, 29 • Minimal reporting of outcome measures relating to return to sport • Minimal reporting of objective, functional outcomes • Complication rates were consistently low across all four studies • No follow up greater than 5 years
Generalisability C-satisfactory Population/s studied in body of evidence differ to target population for guideline but it is clinically sensible to apply this evidence to target population • Higher percentage of male subjects • Age range 18 to 56. One study only provided mean ages of 30.9 and 31 for intervention groups.29 • Co-pathologies (previous ACL rupture, associated meniscal or ligamentous injuries), were included in three studies.8, 28-29 • All studies used chronic populations. Two study also included acute presentations (< 3 months)8, 27 • Mechanism of injury poorly reported • Operative procedure times not reported
Grade of recommendation D Caution Body of evidence is weak and recommendation must be applied with caution Current evidence suggests that the use of LARS as a surgical intervention for the treatment of symptomatic ACL deficiency must be considered with caution. Routine use of LARS should be underpinned with regular monitoring of outcomes (subjective and objective) using psychometrically sound instruments. Due to the volume and quality of evidence, current literature on this topic should be interpreted with care.