NCT02542566

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 6, 2017

Status Verified

September 1, 2015

Enrollment Period

1.4 years

First QC Date

September 3, 2015

Last Update Submit

April 4, 2017

Conditions

Defect of Articular Cartilage

Outcome Measures

Primary Outcomes (1)

  • Modified Tegner/Lysholm score from questionnaires.

    12 months

Secondary Outcomes (2)

  • Time to return to work.

    12 months

  • Time to return to sporting activities

    12 months

Study Arms (2)

early weight bearing

ACTIVE COMPARATOR

early weight bearing and accelerated physiotherapy rehabilitation

Procedure: Physiotherapy rehabilitation

protected weight bearing

ACTIVE COMPARATOR

protected weight bearing and conservative physiotherapy rehabilitation.

Procedure: Physiotherapy rehabilitation

Interventions

Physiotherapy rehabilitationPROCEDURE

Physiotherapy rehabilitation

early weight bearingprotected weight bearing

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

Study Officials

  • Peter Gallacher, Surgeon

    NHS Healthcare

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 7, 2015

Study Start

January 21, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 6, 2017

Record last verified: 2015-09

Locations

GB(1)