Accelerated vs Non-Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction: A Pilot Study (AVON ACL)
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|ClinicalTrials.gov Identifier: NCT03648944|
Recruitment Status : Terminated
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Reconstruction||Other: Accelerated Rehabillitation Other: Non-Accelerated Rehabillitation||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- IKDC data completion [ Time Frame: 15 months ]As a measure of the feasibility of the study design
- KOOS data completion [ Time Frame: 15 months ]As a measure of the feasibility of the study design
- Tegner data completion [ Time Frame: 15 months ]As a measure of the feasibility of the study design
- EQ5D data completion [ Time Frame: 15 months ]As a measure of the feasibility of the study design
- Anterior/Posterior knee translation completion [ Time Frame: 15 months ]As a measure of the feasibility of the study design
- Lower Limb Symmetry completion [ Time Frame: 15 months ]As a measure of the feasibility of the study design
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
|North Bristol NHS Trust|
|Bristol, United Kingdom, BS10 5NB|
|Principal Investigator:||James Robinson, MBBS, FRCS (Orth)||North Bristol NHS Trust|