Osteochondral DefectNCT03452098
Post-Operative Rehabilitation of Knee Osteochondral Defect: A Case Series
An observational study of Osteochondral Defect and Osteochondritis Dissecans, run by California State University, Northridge at 1 site in United States.
Trial summary
A case-series review was performed on five collegiate athletes with osteochondral lesions of the knee at California State University, Northridge (CSUN). All subjects received surgical intervention to treat the defect. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteochondral Defect, Osteochondritis Dissecans
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subjects were recruited from a population of student athletes at California State University, Northridge. These athletes were being treated by the Physical Therapy and/or Athletic Training Departments for Osteochondral Defect of the knee.
Who may be able to join
- Student athlete at CSUN
- Diagnosed with Osteochondral dissecans (OCD)
- Underwent surgical procedure to treat OCD
- Treated postoperatively by the team physical therapist and/or athletic trainers at CSUN.
Who cannot join
- No concurrent ligamentous injures to the knee during the time of subject participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
California State University, Northridge
Northridge, California, 91330
About this study
Official title: Examination and Post-operative Rehabilitation of University Athletes With Osteochondral Lesions of the Knee: A Case Series Report
A case-series review was performed on five collegiate athletes with osteochondral lesions of the knee at California State University, Northridge (CSUN). All subjects received surgical intervention to treat the defect. The surgeries performed were either an Osteoarticular Transfer System (OATS) procedure and/or a Microfracturing procedure. Subjects were treated post-operatively by the CSUN team physical therapist and/or athletic trainers at CSUN. This paper seeks to provide information about osteochondral defects of the knee, the surgical interventions, and a protocol for post-operative treatment and rehabilitation of such injuries.
- Conditions
- Osteochondral Defect, Osteochondritis Dissecans
- Medical subject headings
- Osteochondritis Dissecans
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Function
Determined by subject's ability to return to play of his/her respective sport
Measured: Through study completion; an average of 6 months
Secondary outcomes (1)
Pain
Pain as measured by the Visual Analog Scale (VAS), 0 (No pain) - 10 (Severe Pain)
Measured: Monthly until the completion of the study; an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study startJan 2011
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral DefectStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Northridge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimie Kachingwe, PT, DPT, EdD, OCS, FAAOMPT, Principal investigator, CSUN Physical Therapy Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452098
- Sponsor's protocol ID
- IRB-FY18-11
- Status last verified
- Feb 2019
- First submitted
- 9 Feb 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination and Post-operative Rehabilitation of University Athletes With Osteochondral Lesions of the Knee: A Case Series Report
- ClinicalTrials.gov ID
- NCT03452098
- Acronym / sponsor ID
- IRB-FY18-11
- Conditions
- Osteochondral Defect, Osteochondritis Dissecans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- California State University, NorthridgeUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A case-series review was performed on five collegiate athletes with osteochondral lesions of the knee at California State University, Northridge (CSUN). All subjects received surgical intervention to treat the defect. The surgeries performed were either an Osteoarticular Transfer System (OATS) procedure and/or a Microfracturing procedure. Subjects were treated post-operatively by the CSUN team physical therapist and/or athletic trainers at CSUN. This paper seeks to provide information about osteochondral defects of the knee, the surgical interventions, and a protocol for post-operative treatment and rehabilitation of such injuries.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects were recruited from a population of student athletes at California State University, Northridge. These athletes were being treated by the Physical Therapy and/or Athletic Training Departments for Osteochondral Defect of the knee.
Key inclusion criteria (4 listed)
- Student athlete at CSUN
- Diagnosed with Osteochondral dissecans (OCD)
- Underwent surgical procedure to treat OCD
- Treated postoperatively by the team physical therapist and/or athletic trainers at CSUN.
Key exclusion criteria (1 listed)
- No concurrent ligamentous injures to the knee during the time of subject participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of Function
Time frame: Through study completion; an average of 6 months
Determined by subject's ability to return to play of his/her respective sport
1 secondary outcome
Pain
Time frame: Monthly until the completion of the study; an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
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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.
Aimie Kachingwe, PT, DPT, EdD, OCS, FAAOMPT principal investigator
CSUN Physical Therapy Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteochondral Defect and Osteochondritis Dissecans, run by California State University, Northridge 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 4 inclusion and 1 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 11 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of Function (time frame: Through study completion; an average of 6 months). 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 11 Feb 2019.