Cartilage LossMfxbracingNCT02016300
Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects
A study testing Unloader Bracing and Non-Bracing in people with Cartilage Loss and Microfracture, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cartilage Loss, Microfracture
- What is being tested?
- Unloader Bracing and Non-Bracing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
- age 15-40
- neutral knee alignment
Who cannot join
- prior cartilage procedures performed in the same knee
- other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Redwood City, California, 94063
About this study
Official title: 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.
Read the 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.
- Conditions
- Cartilage Loss, Microfracture
- Being tested
- Unloader Bracing, Non-Bracing
- Keywords
- cartilage, microfracture, knee, bracing
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unloader BracingDevice
Also called Ossur Unloader Brace
The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
Non-BracingDevice
Microfracture performed with no post-operative unloader bracing
| Study group | Role | What they receive |
|---|---|---|
| Unloader Bracing | Experimental | This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period. Receives: Device: Unloader Bracing |
| Non-Bracing Arm | Active comparator | This group will be randomly selected and assigned to wear no brace post-operatively. Receives: Device: Non-Bracing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Change From Baseline in Cartilage Volume (Radiographic Outcome)
Measured: 2 years
Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cartilage LossStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason L. Dragoo, Stanford University
- Investigators
- Jason Dragoo, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016300
- Sponsor's protocol ID
- oss-mfx-2013
- Acronym
- Mfxbracing
- Status last verified
- May 2019
- First submitted
- 2 Dec 2013
- Last updated
- 27 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects
- ClinicalTrials.gov ID
- NCT02016300
- Acronym / sponsor ID
- Mfxbracing / oss-mfx-2013
- Conditions
- Cartilage Loss, Microfracture
- Keywords
- cartilage, microfracture, knee, bracing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Posted 27 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unloader Bracing | Experimental | Device: Unloader BracingThis group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period. |
| Non-Bracing Arm | Active comparator | Device: Non-BracingThis group will be randomly selected and assigned to wear no brace post-operatively. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
- age 15-40
- neutral knee alignment
Key exclusion criteria (2 listed)
- prior cartilage procedures performed in the same knee
- other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unloader BracingAlso: Ossur Unloader BraceThe bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period. | Device | Unloader Bracing |
| Non-BracingMicrofracture performed with no post-operative unloader bracing | Device | Non-Bracing Arm |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
Time frame: 2 years
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.
6 secondary outcomes
Change From Baseline in Tegner Score (Clinical Outcome)
Time frame: 2 years
Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
Time frame: 2 years
Change From Baseline in Lysholm Score (Clinical Outcome)
Time frame: 2 years
Change From Baseline in T2 Relaxation Time (Radiographic Outcome)
Time frame: 2 years
Change From Baseline in Cartilage Volume (Radiographic Outcome)
Time frame: 2 years
Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cartilage Loss
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
Recruiting
Efficacy of Bioceramic Materials for Bone Defects Repair
Bone Lesion, Cartilage Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Dragoo, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unloader Bracing and Non-Bracing in people with Cartilage Loss and Microfracture, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.