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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Spring Loaded Tri-Compartment Unloader Knee Brace Study

NCT05428332

Anterior Knee Pain

COMPLETED NA

Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects

NCT02090140

Degenerative Lesion of Articular Cartilage of Knee

RECRUITING NA

Efficacy Study of an Unloading Brace for Knee Osteoarthritis

NCT02150057

Osteoarthritis of the Knee

COMPLETED NA

Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

NCT00945399

Knee Chondral Osteochondral Defect

TERMINATED PHASE3

Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions

NCT02981355

Traumatic; Lesion Degenerative Lesion of Articular Cartilage of Knee

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cartilage Loss Microfracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Unloader Bracing

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

Group Type EXPERIMENTAL

Unloader Bracing

Intervention Type DEVICE

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

Non-Bracing Arm

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

Group Type ACTIVE_COMPARATOR

Non-Bracing

Intervention Type DEVICE

Microfracture performed with no post-operative unloader bracing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Unloader Bracing

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

Intervention Type DEVICE

Non-Bracing

Microfracture performed with no post-operative unloader bracing

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ossur Unloader Brace

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes