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Clinical Trials/NCT06318039
NCT06318039Not yet recruitingNot Applicable

Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction

Linnaeus University2 sites in 1 country100 target enrollmentStarted: October 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
2
Primary Endpoint
Isokinetic muscle strength

Study Overview

Brief Summary

Scientific Research Question

Overall Purpose:

Regarding rehabilitation after anterior cruciate ligament reconstruction (ACLR), there is a knowledge gap - a lack of evidence. Important questions such as how rehabilitation should be structured, what it should include, and how it should be evaluated are currently not clear. Therefore, the investigators plan to conduct a two-year follow-up randomized controlled trial (RCT) on post-ACLR rehabilitation.

Moreover, detailed information on how/under what circumstances the ACL injury occurred is not satisfactorily described in the literature. Therefore, the investigators are planning a new survey that can identify, explain, and prevent the risk factors causing a person to suffer from an anterior cruciate ligament injury.

Specific Objectives:

How should guidelines for rehabilitation after ACLR be structured, what should they include, and how should they be evaluated to best restore knee function in the patient? Can a detailed and comprehensive survey identify, explain, and prevent the risk factors causing a person to suffer from an ACL injury?

Detailed Description

The overall aim of the project is to improve the physiotherapeutic guidelines to enhance the quality of rehabilitation for patients with surgically repaired anterior cruciate ligament (ACL) injuries. ACL injury is a severe knee injury that often prevents young individuals from continuing sports activities at their desired level. It can eventually lead to knee osteoarthritis within 10-15 years after the initial injury. Despite existing research on preventive training for young athletes in high-risk sports such as soccer, handball, and floorball, this injury remains common. ACL injury in young female athletes engaged in contact sports is 2-5 times more prevalent compared to young males. Regarding rehabilitation after ACL reconstruction, literature often indicates inadequacies where full muscle strength or jumping ability has not been regained. Despite this, patients often return to sports activities, which may increase the risk of re-injury. Guidelines for structuring rehabilitation, its content, and evaluation need improvement accordingly.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Athletes or recreational athletes that have undergone ACLR

Exclusion Criteria

  • Patients that have undergone ACLR that are nor athletes or recreational athletes

Outcomes

Primary Outcomes

Isokinetic muscle strength

Time Frame: Tests at 8, 12, 18 and 24 months post-ACLR.

Test of each patient's unilateral maximal isokinetic muscle strength for the involved and the uninvolved leg, using an isokinetic dynamometer (Biodex isokinetic dynamometry system 4).

Single-leg hop performance

Time Frame: Tests at 8, 12, 18 and 24 months post-ACLR.

Test of each patient's single-leg hop performance for the involved and the uninvolved leg. The goal is to have a less than 10% difference in hop distance between the injured limb and uninjured limb.

Secondary Outcomes

  • ACL Return to Sport after Injury scale(Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS)(Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.)

Investigators

Sponsor
Linnaeus University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jesper Augustsson

PhD, Associate Professor

Linnaeus University

Study Sites (2)

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