Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06318039
• Other study ID #: IRB2022-06554-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: October 1, 2027

Study information

• Verified date: April 2024
• Source: Linnaeus University
• Contact: Jesper Augustsson, PhD
• Phone: +46705589752
• Email: jesper.augustsson[@]lnu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Athletes or recreational athletes that have undergone ACLR

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Other:
• Novel program
Applying new training method; the Nordic hamstring exercise
• Traditional program
Conventional rehabilitation training administered

Locations

Country	Name	City	State
Sweden	Linnaeus University	Kalmar	Sverige

Sponsors (1)

Lead Sponsor	Collaborator
Linnaeus University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isokinetic muscle strength	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).	Tests at 8, 12, 18 and 24 months post-ACLR.
Primary	Single-leg hop performance	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.	Tests at 8, 12, 18 and 24 months post-ACLR.
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee Injury and Osteoarthritis Outcome Score (KOOS) evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.	Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.
Secondary	ACL Return to Sport after Injury scale	The ACL - Return to Sport after Injury (ACL-RSI) scale measure athletes' emotion, confidence, and risk appraisal when returning to sports after an ACL injury and/or reconstructive surgery. The survey consists of 12 items that are graded on a visual analogue scale from 0 points (extremely negative psychological responses) to 100 points (no negative psychological responses).	Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.

External Links

•   The project's homepage