Osteochondritis DissecansNCT02397278
Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee
A study testing Platelet rich plasma (PRP) in people with Osteochondritis Dissecans, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about ways to treat a joint problem in the knee called Juvenile Osteochondritis Dissecans (OCD). The goal of this study is to see if injecting platelet-rich plasma (PRP) into the knee can help knee cartilage heal faster, and will try to determine whether the injections lead to… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Osteochondritis Dissecans
- What is being tested?
- Platelet rich plasma (PRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 8 Jan 2020
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female age 10 - 17 inclusive with open physis confirmed by MRI
- Documented symptomatic stable juvenile osteochondritis dissecans of the knee based on MRI without changes of osteoarthritis and no prior history of knee surgery.
- The patient must be able to hold still without sedation for approximately 1 hour and must pass MRI screening evaluation for retained metal.
- Patients with Di Paola stage 1 or 2 lesions
Who cannot join
- Patients with polyarticular disease.
- Patients with blood disorders (Blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin <9g/dL). Only those patients with a positive history of blood disorders will have a Complete Blood Count (CBC) performed a week prior to inclusion in the study.
- Patients who had intra-articular treatment with steroids within 3 months
- Patients who are pregnant or nursing at the time of consent.
- Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
- Non-English speaking patients. (Scores used for evaluation have not been validated in Spanish)
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- Patients who had previous knee surgery
- Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
- Chronic use of NSAID (defined as taking non-steroidal anti-inflammatory drug) regularly every week for the last 6 months), steroids or chemotherapy drugs
- Treatment with NSAIDs within 15 days prior to randomization in this study
- Patients with a BMI over 30. Due to the fact that this study utilizes an injection technique which may be inaccurate in obese subjects.
- Patients with a prolongation of bleeding time, e.g. those receiving anticoagulant drug therapy
- Patients with a contraindication to MRI including: patients with cardiac pacemaker or non-approved intracranial vascular clip, and those with orthopedic hardware as the resulting artifact can complicate interpretation
- Patients with acute or chronic renal failure
- Patients with a previous anaphylactic reaction to gadolinium enhanced MRI.
- Patients with Di Paola stage 3 or 4 lesions
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee: Does it Help? A Clinical and Magnetic Resonance Imaging (MRI) Study.
This study plans to learn more about ways to treat a joint problem in the knee called Juvenile Osteochondritis Dissecans (OCD). The goal of this study is to see if injecting platelet-rich plasma (PRP) into the knee can help knee cartilage heal faster, and will try to determine whether the injections lead to improvements in pain, performance of activities of daily living, improvements is sports activities and overall function and symptoms reduction. The investigators will compare PRP treatment to conservative therapy.
- Conditions
- Osteochondritis Dissecans
- Being tested
- Platelet rich plasma (PRP)
- Medical subject headings
- Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma (PRP)Drug
Also called autologous PRP
Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma (PRP) | Active comparator | Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. Receives: Drug: Platelet rich plasma (PRP) |
| Conventional therapy | No intervention | Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI
Measured by dGEMRIC MRI
Measured: 6 months
Secondary outcomes (4)
Improvement in Pain, Performance and Overall Function: IKDC
Measured by the Pediatric IKDC survey results. The International Knee Documentation Committee questionnaire measures knee function, Scores range from 1-100, with higher scores indicating a better outcome.
Measured: Baseline, 6 months, 12 months
Improvement in Pain, Performance and Overall Function: KOOS, Baseline
Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome.
Measured: Baseline
Improvement in Pain, Performance and Overall Function: KOOS, 6 Months
Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome.
Measured: 6 Months
Improvement in Pain, Performance and Overall Function: KOOS, 12 Months
Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
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 Osteochondritis DissecansStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Model description
- Arm 1- Conservative Treatment Arm 2- PRP Injections
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo BCT
- Responsible party
- Sponsor
- Investigators
- Michael Fadell, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397278
- Sponsor's protocol ID
- 13-2797
- Status last verified
- Jul 2021
- First submitted
- 24 Feb 2015
- Last updated
- 5 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee: Does it Help? A Clinical and Magnetic Resonance Imaging (MRI) Study.
- ClinicalTrials.gov ID
- NCT02397278
- Acronym / sponsor ID
- 13-2797
- Conditions
- Osteochondritis Dissecans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Terumo BCT
- Study start
- Mar 2015 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Posted 5 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to learn more about ways to treat a joint problem in the knee called Juvenile Osteochondritis Dissecans (OCD). The goal of this study is to see if injecting platelet-rich plasma (PRP) into the knee can help knee cartilage heal faster, and will try to determine whether the injections lead to improvements in pain, performance of activities of daily living, improvements is sports activities and overall function and symptoms reduction. The investigators will compare PRP treatment to conservative therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1- Conservative Treatment Arm 2- PRP Injections
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma (PRP) | Active comparator | Drug: Platelet rich plasma (PRP)Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. |
| Conventional therapy | No intervention | –Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female age 10 - 17 inclusive with open physis confirmed by MRI
- Documented symptomatic stable juvenile osteochondritis dissecans of the knee based on MRI without changes of osteoarthritis and no prior history of knee surgery.
- The patient must be able to hold still without sedation for approximately 1 hour and must pass MRI screening evaluation for retained metal.
- Patients with Di Paola stage 1 or 2 lesions
Key exclusion criteria (16 listed)
- Patients with polyarticular disease.
- Patients with blood disorders (Blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin <9g/dL). Only those patients with a positive history of blood disorders will have a Complete Blood Count (CBC) performed a week prior to inclusion in the study.
- Patients who had intra-articular treatment with steroids within 3 months
- Patients who are pregnant or nursing at the time of consent.
- Patients with inflammatory arthritic conditions (e.g. rheumatoid 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 |
|---|---|---|
| Platelet rich plasma (PRP)Also: autologous PRPPatient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy. | Drug | Platelet rich plasma (PRP) |
Primary outcome
Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI
Time frame: 6 months
Measured by dGEMRIC MRI
4 secondary outcomes
Improvement in Pain, Performance and Overall Function: IKDC
Time frame: Baseline, 6 months, 12 months
Improvement in Pain, Performance and Overall Function: KOOS, Baseline
Time frame: Baseline
Improvement in Pain, Performance and Overall Function: KOOS, 6 Months
Time frame: 6 Months
Improvement in Pain, Performance and Overall Function: KOOS, 12 Months
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Fadell, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma (PRP) in people with Osteochondritis Dissecans, run by University of Colorado, Denver 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 16 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 5 Aug 2021. 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 5 Aug 2021). 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?
Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI (time frame: 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 5 Aug 2021.