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

NCT02016300 | Completed Results DMC

• 1 other identifier: oss-mfx-2013
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cartilage Loss; Microfracture

Keywords

cartilage; microfracture; knee; bracing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change From Baseline in Tegner Score (Clinical Outcome)

  2 years

• Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)

  2 years

• Change From Baseline in Lysholm Score (Clinical Outcome)

  2 years

• Change From Baseline in T2 Relaxation Time (Radiographic Outcome)

  2 years

• Change From Baseline in Cartilage Volume (Radiographic Outcome)

  2 years

Study Arms (2)

Unloader Bracing

EXPERIMENTAL

This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.

Device: Unloader Bracing

Non-Bracing Arm

ACTIVE COMPARATOR

This group will be randomly selected and assigned to wear no brace post-operatively.

Device: Non-Bracing

Interventions

Unloader Bracing DEVICE

The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.

Also known as: Ossur Unloader Brace

Unloader Bracing

Non-Bracing DEVICE

Microfracture performed with no post-operative unloader bracing

Non-Bracing Arm

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Results Point of Contact

• Title: Jason Dragoo, MD
• Organization: Stanford University

jdragoo@stanford.edu

650-721-3430

Study Officials

• Jason Dragoo, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 19, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 27, 2019
• Results First Posted: June 27, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)