Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648944
Recruitment Status : Terminated
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
North Bristol NHS Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Other: Accelerated Rehabillitation Other: Non-Accelerated Rehabillitation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerated vs Non-Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction: A Pilot Study
Study Start Date : December 2014
Actual Primary Completion Date : September 19, 2016
Actual Study Completion Date : September 19, 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. IKDC data completion [ Time Frame: 15 months ]
    As a measure of the feasibility of the study design

  2. KOOS data completion [ Time Frame: 15 months ]
    As a measure of the feasibility of the study design

  3. Tegner data completion [ Time Frame: 15 months ]
    As a measure of the feasibility of the study design

  4. EQ5D data completion [ Time Frame: 15 months ]
    As a measure of the feasibility of the study design

  5. Anterior/Posterior knee translation completion [ Time Frame: 15 months ]
    As a measure of the feasibility of the study design

  6. Lower Limb Symmetry completion [ Time Frame: 15 months ]
    As a measure of the feasibility of the study design



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648944


Locations
Layout table for location information
United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom, BS10 5NB
Sponsors and Collaborators
North Bristol NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: James Robinson, MBBS, FRCS (Orth) North Bristol NHS Trust

Layout table for additonal information
Responsible Party: North Bristol NHS Trust
ClinicalTrials.gov Identifier: NCT03648944    
Other Study ID Numbers: R&I 3181
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: October 2014
Keywords provided by North Bristol NHS Trust:
Rehabilitation Outcome