Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects (Mfxbracing)

Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects

The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.

The surgery performed will be the same for all patients

The length of follow up and schedule of post-operative MRI will be the same for all patients.

The only difference in groups will be presence of absence of brace wear.

Study Overview

• Status: Completed
• Conditions: Microfracture; Cartilage Loss
• Intervention / Treatment: Device: Unloader Bracing; Device: Non-Bracing

Detailed Description

The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.

The surgery performed will be the same for all patients

The length of follow up and schedule of post-operative MRI will be the same for all patients.

The only difference in groups will be presence of absence of brace wear.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
• age 15-40
• neutral knee alignment

Exclusion Criteria:

• prior cartilage procedures performed in the same knee
• other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unloader Bracing; This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.	Device: Unloader Bracing; The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.; Other Names: Ossur Unloader Brace
Active Comparator: Non-Bracing Arm; This group will be randomly selected and assigned to wear no brace post-operatively.	Device: Non-Bracing; Microfracture performed with no post-operative unloader bracing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)	KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Tegner Score (Clinical Outcome)	The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport.	2 years
Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)	SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life. A higher value indicates a better quality of life of the patient. The scores range from 0 to 100.	2 years
Change From Baseline in Lysholm Score (Clinical Outcome)	The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.	2 years
Change From Baseline in T2 Relaxation Time (Radiographic Outcome)	T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.	2 years
Change From Baseline in Cartilage Volume (Radiographic Outcome)		2 years
Change From Baseline in Cartilage Thickness (Radiographic Outcome)		2 years

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Jason Dragoo, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: knee; cartilage; bracing; microfracture
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Stress
• Other Study ID Numbers: oss-mfx-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO