Accelerated vs Non-Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction: A Pilot Study

NCT03648944 | Terminated

• 1 other identifier: R&I 3181
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

Rehabilitation Outcome

Outcome Measures

Primary Outcomes (6)

• IKDC data completion

  As a measure of the feasibility of the study design

  15 months

• KOOS data completion

  As a measure of the feasibility of the study design

  15 months

• Tegner data completion

  As a measure of the feasibility of the study design

  15 months

• EQ5D data completion

  As a measure of the feasibility of the study design

  15 months

• Anterior/Posterior knee translation completion

  As a measure of the feasibility of the study design

  15 months

• Lower Limb Symmetry completion

  As a measure of the feasibility of the study design

  15 months

Study Arms (2)

Accelerated Rehabilitation

EXPERIMENTAL

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

Non-Accelerated

ACTIVE COMPARATOR

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

Interventions

Accelerated Rehabillitation OTHER

Accelerated Rehabilitation

Non-Accelerated Rehabillitation OTHER

Non-Accelerated

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• North Bristol NHS Trust: lead

Study Sites (1)

North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

Location

Study Officials

• James Robinson, MBBS, FRCS (Orth)

  North Bristol NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: August 28, 2018
• Study Start: December 1, 2014
• Primary Completion: September 19, 2016
• Study Completion: September 19, 2016
• Last Updated: August 28, 2018

Record last verified: 2014-10

Locations

GB (1)