Protected Versus Early Weight Bearing Post Microfracture Surgery

Defect of Articular Cartilage Clinical Trial

Official title:

Randomised Control Trial Comparing Conservative Rehabilitation and Protected Weight Bearing Versus Accelerated Rehabilitation and Early Weight Bearing Post Microfracture Knee Surgery.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02542566
• Other study ID #: version 4 28/08/2014
• Status: Terminated
• Phase: N/A
• First received: September 3, 2015
• Last updated: April 4, 2017
• Start date: January 21, 2015
• Est. completion date: July 1, 2016

Study information

• Verified date: September 2015
• Source: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cartilage Diseases
• Defect of Articular Cartilage

Intervention

Procedure:
• Physiotherapy rehabilitation
Physiotherapy rehabilitation

Locations

Country	Name	City	State
United Kingdom	The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT	Oswestry	Shropshire

Sponsors (1)

Lead Sponsor	Collaborator
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Tegner/Lysholm score from questionnaires.		12 months
Secondary	Time to return to work.		12 months
Secondary	Time to return to sporting activities		12 months