Accelerated vs Non-Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction: A Pilot Study (AVON ACL)

August 23, 2018 updated by: North Bristol NHS Trust
This study is comparing accelerated versus nonaccelerated rehabilitation following ACL reconstruction. Patients undergoing ACL reconstruction will be randomly allocated to one of the two rehabillitation pathways. They will then be monitored over a 15 month period.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The anterior cruciate ligament (ACL) is a vital structure within the knee that provides the stability of the joint. Injury to the ACL is a common injury of the knee affecting young adults, usually whilst playing sport.

Surgical reconstruction of complete ACL rupture aims to restore stability of the knee, reduce pain and swelling, limit future arthritic change, maximise knee function and allow patients to return to preinjury recreational and sporting activity. It has been suggested that the success of an ACL reconstruction is dependent upon the postoperative rehabilitation process.

There is no consensus on the best rehabilitation following ACL reconstruction. Traditional, nonaccelerated, rehabilitation programmes emphasise protection of the ACL graft, modelled on the stages of graft healing. This includes postoperative immobilisation, limiting how much the knee can be straightened, restricted weight bearing and delayed return to activity with most patients returning to activity at 1 year. Complications have however been identified with nonaccelerated rehabilitation. This includes ongoing muscle weakness, inability to fully straighten the knee, and knee cap pain at 1 year followup. To address these issues alternative, accelerated, rehabilitation programmes have been developed. These have included allowing full movement, earlier weight bearing and earlier return to activity, with no adverse sequalae.

The uncertainty in the benefit of accelerated rehabilitation over conventional nonaccelerated protocols warrants further investigation in order determine whether accelerated protocols improve knee muscle function and clinical outcome in the longterm, and provide a more effective practice for treating patients following ACL reconstruction, or whether they pose an increased risk of reinjury by permitting early return to higher level activity.

This study is a single centre randomized controlled trial comparing accelerated versus nonaccelerated rehabilitation protocols with the use of clinical and patient reported outcome measures over a 15month period following ACL reconstruction.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • North Bristol NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients aged 16 years or over, listed for primary ACL reconstruction using hamstring grafts at North Bristol NHS Trust.

Exclusion Criteria:

  • Patients listed for double bundle ACL reconstruction.
  • Patients listed for multiple ligament reconstruction.
  • Patients listed for revision reconstructive surgery of the knee.
  • Previous history of lower limb arthroplasty.
  • Previous history of knee injury in either knee, e.g. meniscal tears, previous ligament injuries.
  • Patients unable to understand or read English (the outcome measures being utilised have been validated or published in the English language only).
  • Patients unable to comply with the study protocol.
  • Patients unable to attend for rehabilitation at North Bristol NHS Trust.
  • Meniscal repairs resulting in subsequent modification to the rehabilitation protocol (e.g. altered weight bearing, brace).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Accelerated Rehabilitation
Participants in this arm will have fewer restrictions on their mobility post-operatively and will be permitted to return to more active sporting activities quicker.
Other: Accelerated Rehabillitation
Active Comparator: Non-Accelerated
Participants in this arm will be fitted with a knee brace and be restricted in their weight bearing post-operatively. They will also be restricted from returning to active sporting activities too quickly.
Other: Non-Accelerated Rehabillitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IKDC data completion
Time Frame: 15 months
As a measure of the feasibility of the study design
15 months
KOOS data completion
Time Frame: 15 months
As a measure of the feasibility of the study design
15 months
Tegner data completion
Time Frame: 15 months
As a measure of the feasibility of the study design
15 months
EQ5D data completion
Time Frame: 15 months
As a measure of the feasibility of the study design
15 months
Anterior/Posterior knee translation completion
Time Frame: 15 months
As a measure of the feasibility of the study design
15 months
Lower Limb Symmetry completion
Time Frame: 15 months
As a measure of the feasibility of the study design
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Bristol NHS Trust

Investigators

  • Principal Investigator: James Robinson, MBBS, FRCS (Orth), North Bristol NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

September 19, 2016

Study Completion (Actual)

September 19, 2016

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

August 23, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R&I 3181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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