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Protected Versus Early Weight Bearing Post Microfracture Surgery

Primary Purpose

Defect of Articular Cartilage

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Physiotherapy rehabilitation
Sponsored by
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Defect of Articular Cartilage

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 16-60 years. Mechanically stable knee joint at outpatient examination. MRI confirmed grade 3 or 4 non-kissing cartilage defect within the knee. Able to fully understand the process and study and give informed consent to participate.

Able to comply with the physiotherapy rehabilitation and follow up process.

Exclusion Criteria:

  • Kissing cartilage defects. Defects deemed too large to undergo microfracture on MRI scan. Clinically unstable knee joint. Patients unable to consent to participation. Under 16 years of age or over 60 years of age. Patients likely to drop out of physiotherapy rehabilitation and study follow up.

Sites / Locations

  • The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

early weight bearing

protected weight bearing

Arm Description

early weight bearing and accelerated physiotherapy rehabilitation

protected weight bearing and conservative physiotherapy rehabilitation.

Outcomes

Primary Outcome Measures

Modified Tegner/Lysholm score from questionnaires.

Secondary Outcome Measures

Time to return to work.
Time to return to sporting activities

Full Information

First Posted
September 3, 2015
Last Updated
April 4, 2017
Sponsor
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02542566
Brief Title
Protected Versus Early Weight Bearing Post Microfracture Surgery
Official Title
Randomised Control Trial Comparing Conservative Rehabilitation and Protected Weight Bearing Versus Accelerated Rehabilitation and Early Weight Bearing Post Microfracture Knee Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped prematurely due to the lack of eligible participants.
Study Start Date
January 21, 2015 (Actual)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
July 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee.
Detailed Description
To test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee. Current practice in most units is to protect patients from weight bearing prior to entering a conservative physiotherapy rehabilitation program following microfracture surgery of the knee. At our unit we believe that protecting patients from weight bearing post microfracture surgery makes no difference to their outcome and only leads to a longer rehabilitation time and a delayed return to work and sports. Therefore we want to randomise patients who require microfracture surgery of the knee for cartilage defects into 2 post operative rehabilitation groups. One group will be able to weight bear early and will undergo an accelerated rehabilitation program whilst the other will be protected from weight bearing and will undergo a more conservative rehabilitation program. We will then follow patients up over a year and compare outcome data collected at 6 weeks, 3 months, 6 months and 1 year post operatively to see if there was any difference in outcomes between the 2 groups. As secondary outcomes we will also compare the patients in the two groups to see if there is a difference in time taken to return to work and sporting activities

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Defect of Articular Cartilage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early weight bearing
Arm Type
Active Comparator
Arm Description
early weight bearing and accelerated physiotherapy rehabilitation
Arm Title
protected weight bearing
Arm Type
Active Comparator
Arm Description
protected weight bearing and conservative physiotherapy rehabilitation.
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy rehabilitation
Intervention Description
Physiotherapy rehabilitation
Primary Outcome Measure Information:
Title
Modified Tegner/Lysholm score from questionnaires.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to return to work.
Time Frame
12 months
Title
Time to return to sporting activities
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 16-60 years. Mechanically stable knee joint at outpatient examination. MRI confirmed grade 3 or 4 non-kissing cartilage defect within the knee. Able to fully understand the process and study and give informed consent to participate. Able to comply with the physiotherapy rehabilitation and follow up process. Exclusion Criteria: Kissing cartilage defects. Defects deemed too large to undergo microfracture on MRI scan. Clinically unstable knee joint. Patients unable to consent to participation. Under 16 years of age or over 60 years of age. Patients likely to drop out of physiotherapy rehabilitation and study follow up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Gallacher, Surgeon
Organizational Affiliation
NHS Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT
City
Oswestry
State/Province
Shropshire
ZIP/Postal Code
SY10 7AG
Country
United Kingdom

12. IPD Sharing Statement

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Protected Versus Early Weight Bearing Post Microfracture Surgery

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