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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
North Bristol NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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