ClinicalTrials.gg
CompletedNCT02397278Updated Aug 5, 2021Results posted

Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee

An interventional study of Platelet rich plasma (PRP) in Osteochondritis Dissecans, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-08-05.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Osteochondritis Dissecans with a site in United States — 4 open to participants now, 4 under way, 1 of them phase 3. Osteochondritis Dissecans · United States.

Started
2015
the only one that year
No phase
6 of 13
2 open now
Registered
6th of 13
by date
Lead sponsor
1 of 13
University of Colorado, Denver

Among the 13 studies in Osteochondritis Dissecans with a site in United States, this one is the only one that started in 2015, is one of 6 with no phase, and was the 6th registered.

Osteochondritis Dissecans

30 studies on the registry are indexed under Osteochondritis Dissecans; 7 are open to participants now.

Browse Osteochondritis Dissecans studies →

Open to participants now

4 of the 13 studies in Osteochondritis Dissecans with a site in United States are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 6 Osteochondritis Dissecans studies recruiting now, 2 set no upper age limit and 4 stop at 75 or younger; 5 take children under 18; none take healthy volunteers.

This study: 10 Years to 17 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Osteochondritis Dissecans with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Osteochondritis Dissecans
04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female age 10 - 17 inclusive with open physis confirmed by MRI
  2. Documented symptomatic stable juvenile osteochondritis dissecans of the knee based on MRI without changes of osteoarthritis and no prior history of knee surgery.
  3. The patient must be able to hold still without sedation for approximately 1 hour and must pass MRI screening evaluation for retained metal.
  4. Patients with Di Paola stage 1 or 2 lesions

Exclusion criteria

Exclusion Criteria:

  1. Patients with polyarticular disease.
  2. Patients with blood disorders (Blood disorders (thrombopathy, thrombocytopenia, anemia with \<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.
  3. Patients who had intra-articular treatment with within 3 months
  4. Patients who are pregnant or nursing at the time of consent.
  5. Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
  6. Non-English speaking patients. (Scores used for evaluation have not been validated in Spanish)
  7. Patients who had previous knee surgery
  8. Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
  9. Chronic use of NSAID (defined as taking non-steroidal anti-inflammatory drug) regularly every week for the last 6 months), steroids or chemotherapy drugs
  10. Treatment with NSAIDs within 15 days prior to randomization in this study
  11. Patients with a over 30. Due to the fact that this study utilizes an injection technique which may be inaccurate in obese subjects.
  12. Patients with a prolongation of bleeding time, e.g. those receiving anticoagulant drug therapy
  13. Patients with a 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
  14. Patients with acute or chronic renal failure
  15. Patients with a previous anaphylactic reaction to gadolinium enhanced MRI.
  16. Patients with Di Paola stage 3 or 4 lesions
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    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.

    Drug: Platelet rich plasma (PRP)

  • No intervention
    Conventional therapy

    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.

Interventions

  • Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.

    Also known as: autologous PRP

06

What researchers measure

Primary outcomes

  1. Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI

    Measured by dGEMRIC MRI

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 6 months, 12 months

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: 6 Months

  4. 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.

    Time frame: 12 Months

Other outcomes

  1. dGemric MRI Findings Correlate With Measures of Functional Recovery and Symptom Reduction.

    Measured by the results of the dGEMRIC MRI and the IKDC and KOOS survey results

    Time frame: 6 months

07

Results

Posted Aug 5, 2021
Limitations and caveats
The 12 month time point for primary and secondary outcome measures was mistakenly omitted from the original registration. This has been corrected to align with the currently approved protocol.

Participant flow

Participant flow — Overall Study
MilestonePlatelet Rich Plasma (PRP)Conventional Therapy
Started78
Completed65
Not completed13
Withdrew: Withdrawal by subject02
Withdrew: Deemed ineligible following surgery11

Outcome measures

PrimaryGreater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI

Measured by dGEMRIC MRI

Time frame:
6 months

No measurements were reported for this outcome.

SecondaryImprovement 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.

Time frame:
Baseline, 6 months, 12 months
Reported as:
Mean · score on a scale
Improvement in Pain, Performance and Overall Function: IKDC
score on a scalePlatelet Rich Plasma (PRP)Conventional Therapy
Baseline48 ± 2152 ± 34
Month 686 ± 2184 ± 20
Month 1284 ± 1890 ± 9
Other pre-specifieddGemric MRI Findings Correlate With Measures of Functional Recovery and Symptom Reduction.

Measured by the results of the dGEMRIC MRI and the IKDC and KOOS survey results

Time frame:
6 months

Results for this outcome have not been posted.

SecondaryImprovement 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.

Time frame:
Baseline
Reported as:
Mean · score on a scale
Improvement in Pain, Performance and Overall Function: KOOS, Baseline
score on a scalePlatelet Rich Plasma (PRP)Conventional Therapy
Pain Subscale56.8 ± 21.650.0 ± 24.6
Symptoms Subscale67.3 ± 24.765.0 ± 17.0
Activities of Daily Living Subscale70.1 ± 24.560.7 ± 25.2
Sport Subscale23.8 ± 21.130.7 ± 42.2
Quality of Life Subscale43.1 ± 19.928.3 ± 20.3
SecondaryImprovement 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.

Time frame:
6 Months
Reported as:
Mean · score on a scale
Improvement in Pain, Performance and Overall Function: KOOS, 6 Months
score on a scalePlatelet Rich Plasma (PRP)Conventional Therapy
Pain Subscale90.6 ± 15.691.4 ± 10.6
Symptoms Subscale84.6 ± 5.489.3 ± 12.3
Activities of Daily Living Subscale95.8 ± 10.296.6 ± 3.9
Sport Subscale88.1 ± 29.269.6 ± 40.6
Quality of Life Subscale68.1 ± 22.653.1 ± 32.5
SecondaryImprovement 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.

Time frame:
12 Months
Reported as:
Mean · score on a scale
Improvement in Pain, Performance and Overall Function: KOOS, 12 Months
score on a scalePlatelet Rich Plasma (PRP)Conventional Therapy
Pain Subscale85.9 ± 16.493.8 ± 8.3
Symptoms Subscale92.9 ± 5.094.0 ± 10.3
Activities of Daily Living Subscale90.5 ± 13.199.2 ± 1.3
Sport Subscale75.6 ± 30.891.7 ± 14.4
Quality of Life Subscale56.9 ± 24.275.0 ± 14.4

Adverse events

Collected over 12 Months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Platelet Rich Plasma (PRP)0/7 (0%)0/7 (0%)0/7 (0%)
Conventional Therapy0/8 (0%)0/8 (0%)0/8 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Platelet Rich Plasma (PRP)Conventional TherapyTotal
<=18 years7815
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)Platelet Rich Plasma (PRP)Conventional TherapyTotal
Mean12 (10 to 13)11.335 (10 to 14)11.6 (10 to 14)
Sex: Female, Male
Sex: Female, Male(Participants)Platelet Rich Plasma (PRP)Conventional TherapyTotal
Female314
Male4711
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Platelet Rich Plasma (PRP)Conventional TherapyTotal
Hispanic or Latino022
Not Hispanic or Latino7613
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Platelet Rich Plasma (PRP)Conventional TherapyTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White7815
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Platelet Rich Plasma (PRP)Conventional TherapyTotal
United States7815
08

Study locations

1 site
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2015 to primary completion in Jan 2020, 58 months.

Results were first posted in Aug 2021, 1 year 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2015
First posted
Mar 24, 2015
StartActual
Mar 2015
Primary completionActual
Jan 8, 2020
CompletionActual
Jan 8, 2020
Results first posted
Aug 5, 2021
Last update
Aug 5, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02397278
Collaborators
Terumo BCT
Responsible party
Sponsor
First posted
Mar 24, 2015
Start date
Mar 2015
Primary completion
Jan 8, 2020
Completion
Jan 8, 2020
Results posted
Aug 5, 2021
Last update
Aug 5, 2021

Study contacts

Michael Fadell, MD
principal investigator · Children's Hospital Colorado

Oversight

Data monitoring committee
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Platelet rich plasma

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