Dataset Information

Treatment for acute anterior cruciate ligament tear: five year outcome of randomised trial.

ABSTRACT:

Objective

To compare, in young active adults with an acute anterior cruciate ligament (ACL) tear, the mid-term (five year) patient reported and radiographic outcomes between those treated with rehabilitation plus early ACL reconstruction and those treated with rehabilitation and optional delayed ACL reconstruction.

Design

Extended follow-up of prospective randomised controlled trial.

Setting

Orthopaedic departments at two hospitals in Sweden.

Participants

121 young, active adults (mean age 26 years) with acute ACL injury to a previously uninjured knee. One patient was lost to five year follow-up.

Intervention

All patients received similar structured rehabilitation. In addition to rehabilitation, 62 patients were assigned to early ACL reconstruction and 59 were assigned to the option of having a delayed ACL reconstruction if needed.

Main outcome measure

The main outcome was the change from baseline to five years in the mean value of four of the five subscales of the knee injury and osteoarthritis outcome score (KOOS(4)). Other outcomes included the absolute KOOS(4) score, all five KOOS subscale scores, SF-36, Tegner activity scale, meniscal surgery, and radiographic osteoarthritis at five years.

Results

Thirty (51%) patients assigned to optional delayed ACL reconstruction had delayed ACL reconstruction (seven between two and five years). The mean change in KOOS(4) score from baseline to five years was 42.9 points for those assigned to rehabilitation plus early ACL reconstruction and 44.9 for those assigned to rehabilitation plus optional delayed reconstruction (between group difference 2.0 points, 95% confidence interval -8.5 to 4.5; P=0.54 after adjustment for baseline score). At five years, no significant between group differences were seen in KOOS(4) (P=0.45), any of the KOOS subscales (P ≥ 0.12), SF-36 (P ≥ 0.34), Tegner activity scale (P=0.74), or incident radiographic osteoarthritis of the index knee (P=0.17). No between group differences were seen in the number of knees having meniscus surgery (P=0.48) or in a time to event analysis of the proportion of meniscuses operated on (P=0.77). The results were similar when analysed by treatment actually received.

Conclusion

In this first high quality randomised controlled trial with minimal loss to follow-up, a strategy of rehabilitation plus early ACL reconstruction did not provide better results at five years than a strategy of initial rehabilitation with the option of having a later ACL reconstruction. Results did not differ between knees surgically reconstructed early or late and those treated with rehabilitation alone. These results should encourage clinicians and young active adult patients to consider rehabilitation as a primary treatment option after an acute ACL tear.

Trial registration

Current Controlled Trials ISRCTN84752559.

SUBMITTER: Frobell RB

PROVIDER: S-EPMC3553934 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundGuided rehabilitation beyond 6-months is rare following anterior cruciate ligament reconstruction (ACLR), despite high prevalence of unacceptable symptoms and quality of life (QoL). Our primary aim was to determine the feasibility of a randomised controlled trial (RCT) evaluating a physiotherapist-guided intervention for individuals 1-year post-ACLR with persistent symptoms. Our secondary aim was to determine if a worthwhile treatment effect could be observed for the lower-limb focussed intervention (compared to the trunk-focussed intervention), for improvement in knee-related QoL, symptoms, and function.DesignParticipant- and assessor-blinded, pilot feasibility RCT.MethodsParticipant eligibility criteria: i) 12-15 months post-ACLR; ii) < 87.5/100 on the Knee injury and Osteoarthritis Outcome Score (KOOS) QoL subscale; and either a one-leg rise test < 22 repetitions, single-hop < 90% limb symmetry; or Anterior Knee Pain Scale < 87/100. Participants were randomised to lower-limb or trunk-focussed focussed exercise and education. Both interventions involved 8 face-to-face physiotherapy sessions over 16-weeks. Feasibility was assessed by eligibility rate (> 1 in 3 screened), recruitment rate (> 4 participants/month), retention (< 20% drop-out), physiotherapy attendance and unsupervised exercise adherence (> 80%). Between-group differences for knee-related QoL (KOOS-QoL, ACL-QoL), symptoms (KOOS-Pain, KOOS-Symptoms), and function (KOOS-Sport, functional performance tests) were used to verify that the worthwhile effect (greater than the minimal detectable change for each measure) was contained within the 95% confidence interval.Results47% of those screened were eligible, and 27 participants (3 participants/month; 48% men, 34±12 years) were randomised. Two did not commence treatment, and two were lost to follow-up (16% drop-out). Physiotherapy attendance was > 80% for both groups but reported adherence to unsupervised exercise was low (< 55%). Both interventions had potentially worthwhile effects for KOOS-QoL and ACL-QoL, while the lower-limb focussed intervention had potentially greater effects for KOOS-Sport, KOOS-Pain, and functional performance.ConclusionsA larger-scale RCT is warranted. All feasibility criteria were met, or reasonable recommendations could be made to achieve the criteria in future trials. Strategies to increase recruitment rate and exercise adherence are required. The potential worthwhile effects for knee-related QoL, symptoms, and function indicates a fully-powered RCT may detect a clinically meaningful effect.Trial registrationProspectively registered ( ACTRN12616000564459 ).

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