Unilateral Primary Osteoarthritis of KneeNCT02285725
Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid
A study testing Microdrilling Surgery and Injections of BMAC + PRP + HA in people with Unilateral Primary Osteoarthritis of Knee and Osteoarthritis Knee, run by Joseph E. Broyles.
Trial summary
This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma (PRP) and hyaluronic acid (HA). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Unilateral Primary Osteoarthritis of Knee, Osteoarthritis Knee, Degeneration; Articular Cartilage, Knee
- What is being tested?
- Microdrilling Surgery and Injections of BMAC + PRP + HA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to 15 Feb 2019
- Phase
- Interventional
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Inflammatory arthritis
- Body mass index (BMI) greater than 35
- Presence of significant varus or valgus knee instability or unusually stiff knee
- Greater than 50% deviation of the mechanical axis
- Presence of active cardiac disease
- Presence of active pulmonary disease
Show all 18Show fewer
- Prior septic arthritis of the involved joint
- Presence of active bacterial or Mycobacterial infection
- Presence of a known hypercoagulable state
- Pregnant or lactating females
- Subject known to be positive for hepatitis B, hepatitis C, or HIV
- Known allergy to hyaluronic acid
- Patients who are unable or unwilling to participate fully in post-operative physical therapy
- Patients with a contraindication to MRI scanning
- Any disorder that compromises ability to give consent or comply with study procedures
- Patients who are felt to be at significantly increased risk for elective orthopedic surgery
- Non-ambulatory patients
- Patients with cognitive impairment
About this study
This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma (PRP) and hyaluronic acid (HA).
- Conditions
- Unilateral Primary Osteoarthritis of Knee, Osteoarthritis Knee, Degeneration; Articular Cartilage, Knee, Degenerative Lesion of Articular Cartilage of Knee
- Being tested
- Microdrilling Surgery, Injections of BMAC + PRP + HA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdrilling SurgeryProcedure or surgery
All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care)
Injections of BMAC + PRP + HAProcedure or surgery
All patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA
| Study group | Role | What they receive |
|---|---|---|
| Augmented Microdrilling Surgery | Experimental | Not described Receives: Procedure: Microdrilling Surgery; Procedure: Injections of BMAC + PRP + HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Knee Documentation Committee (IKDC) score
Measured: Change from baseline at 5 years post-operatively
Secondary outcomes (3)
Joint Space Changes
Evaluated by plain radiographs
Measured: 2 and 5 years post-operatively
MRI appearance of repair cartilage
Evaluated using the MOCART scoring system
Measured: 2 and 5 years post-operatively
Frequency of adverse events requiring additional procedures
Measured: Continuously for 5 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startMar 2011
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Primary Osteoarthritis of KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph E. Broyles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph E. Broyles, Bone and Joint Clinic of Baton Rouge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285725
- Sponsor's protocol ID
- BMPRP1001
- Status last verified
- Jul 2023
- First submitted
- 31 Oct 2014
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid
- ClinicalTrials.gov ID
- NCT02285725
- Acronym / sponsor ID
- BMPRP1001
- Conditions
- Unilateral Primary Osteoarthritis of Knee, Osteoarthritis Knee, Degeneration; Articular Cartilage, Knee, Degenerative Lesion of Articular Cartilage of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Joseph E. BroylesUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 7 Nov 2014 (estimated)
- 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.
This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma (PRP) and hyaluronic acid (HA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented Microdrilling Surgery | Experimental | Procedure: Microdrilling Surgery, Procedure: Injections of BMAC + PRP + HA |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Inflammatory arthritis
- Body mass index (BMI) greater than 35
- Presence of significant varus or valgus knee instability or unusually stiff knee
- Greater than 50% deviation of the mechanical axis
- Presence of active cardiac disease
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 |
|---|---|---|
| Microdrilling SurgeryAll patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care) | Procedure or surgery | Augmented Microdrilling Surgery |
| Injections of BMAC + PRP + HAAll patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA | Procedure or surgery | Augmented Microdrilling Surgery |
Primary outcome
Change in International Knee Documentation Committee (IKDC) score
Time frame: Change from baseline at 5 years post-operatively
3 secondary outcomes
Joint Space Changes
Time frame: 2 and 5 years post-operatively
MRI appearance of repair cartilage
Time frame: 2 and 5 years post-operatively
Frequency of adverse events requiring additional procedures
Time frame: Continuously for 5 years post-operatively
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 27 Jul 2023.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Microdrilling Surgery and Injections of BMAC + PRP + HA in people with Unilateral Primary Osteoarthritis of Knee and Osteoarthritis Knee, run by Joseph E. Broyles.
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 0 inclusion and 18 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 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in International Knee Documentation Committee (IKDC) score (time frame: Change from baseline at 5 years post-operatively). 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 Jul 2023.