Cartilage DiseaseNCT00961597
Assessment of Outcome of Meniscus Repair With or Without Platelet Rich Plasma
A study testing Meniscus repair for red/white tears without PRP and Meniscus repair with PRP in people with Cartilage Disease, run by Sue Barber-Westin at 1 site in United States.
Trial summary
The purpose of this investigation is to determine the clinical outcome of repair of meniscus tears located in the "red/white" region using a well-known suture technique combined, when indicated, with platelet-rich plasma to enhance healing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cartilage Disease
- What is being tested?
- Meniscus repair for red/white tears without PRP and Meniscus repair with PRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled for meniscus repair who provide informed consent to participate
Who cannot join
- Patients scheduled for meniscus repair who refuse to participate
- Presence of a tumor, metastatic disease, active infections, platelet count < 10 5/hl Hgb < 10 g/dl, pregnancy, active breastfeeding, and allergy to Bupivicaine
- Patients with preexisting thrombocytopenia, hypofibrinogenemia, or who are on anti-coagulant therapy, or who have a potential hypersensitivity to bovine products
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Sportsmedicine and Orthopaedic Center
Cincinnati, Ohio, 45242
About this study
Official title: Repair of Human Meniscus Complex Red/White Tears With or Without Platelet-Rich Plasma
The purpose of this investigation is to determine the clinical outcome of repair of meniscus tears located in the "red/white" region using a well-known suture technique combined, when indicated, with platelet-rich plasma to enhance healing. The outcome of this operation will be determined in a consecutive group of patients with an established, rigorous knee rating system a minimum of 2 years postoperatively. Results will be determined by the analysis of subjective and functional factors, sports and occupational activity levels, a comprehensive physical examination, and a radiographic evaluation using standard plain x-rays and magnetic resonance imaging. The investigators hypothesize that meniscus repairs will significantly reduce tibiofemoral compartment pain and allow for increased knee function and activity levels. The platelet rich plasma adjunct will be used in complex meniscus tears in which a portion of the tear extends into the avascular region classified as either longitudinal, horizontal, or radial. The investigators hypothesize that the healing rate of these repairs will be superior to those previously reported in clinical studies in patients who had the suture repair technique alone.
Read the detailed description
There are many published clinical studies of complex meniscus tears in the red/white region with success rates that vary from 57% to 100%. Meniscus repairs that fail in this region usually require subsequent removal, which essentially results in loss of the majority of meniscal function and risk of future disabling osteoarthritis. This study will determine if the addition of platelet rich plasma increases the success rate of complex meniscus repairs of longitudinal, horizontal, or radial tears in the red-white region. The investigators have over two decades of experience with clinical studies of meniscus repairs in patients whose age ranged from 9 to 58 years. Those investigations revealed an average success rate in terms of retention of meniscus tissue of 80%. However, meniscus tears classified as horizontal, radial, double longitudinal, and complex multiplanar had success rates of 71-73% which prompted the need for an adjunct therapeutic measure, such as platelet rich plasma, to increase the healing potential in these cases.
- Conditions
- Cartilage Disease
- Being tested
- Meniscus repair for red/white tears without PRP, Meniscus repair with PRP
- Keywords
- Meniscus, Avascular region, Platelet rich plasma
- Medical subject headings
- Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meniscus repair for red/white tears without PRPProcedure or surgery
Same operation as experimental, only without the use of platelet rich plasma.
Meniscus repair with PRPProcedure or surgery
Meniscus repair with platelet rich plasma using vertical divergent suture techniques.
| Study group | Role | What they receive |
|---|---|---|
| Meniscus repair with PRP | Experimental | Meniscus repair for tears extending into the red/white region with PRP Receives: Procedure: Meniscus repair with PRP |
| Meniscus repair without PRP | Active comparator | Not described Receives: Procedure: Meniscus repair for red/white tears without PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elimination of pain
Measured: Minimum 2 years postoperatively
Secondary outcomes (1)
Magnetic resonance imaging: T2 mapping, signal changes
Measured: Minimum 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sue Barber-Westin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation
- Investigators
- Frank R Noyes, M.D., Principal investigator, Cincinnati Sportsmedicine Research and Education Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961597
- Sponsor's protocol ID
- MenisPRP-001
- Status last verified
- Dec 2014
- First submitted
- 18 Aug 2009
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of Human Meniscus Complex Red/White Tears With or Without Platelet-Rich Plasma
- ClinicalTrials.gov ID
- NCT00961597
- Acronym / sponsor ID
- MenisPRP-001
- Conditions
- Cartilage Disease
- Keywords
- Meniscus, Avascular region, Platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sue Barber-WestinUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Aug 2009 (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.
The purpose of this investigation is to determine the clinical outcome of repair of meniscus tears located in the "red/white" region using a well-known suture technique combined, when indicated, with platelet-rich plasma to enhance healing. The outcome of this operation will be determined in a consecutive group of patients with an established, rigorous knee rating system a minimum of 2 years postoperatively. Results will be determined by the analysis of subjective and functional factors, sports and occupational activity levels, a comprehensive physical examination, and a radiographic evaluation using standard plain x-rays and magnetic resonance imaging. The investigators hypothesize that meniscus repairs will significantly reduce tibiofemoral compartment pain and allow for increased knee function and activity levels. The platelet rich plasma adjunct will be used in complex meniscus tears in which a portion of the tear extends into the avascular region classified as either longitudinal, horizontal, or radial. The investigators hypothesize that the healing rate of these repairs will be superior to those previously reported in clinical studies in patients who had the suture repair technique alone.
Detailed description
There are many published clinical studies of complex meniscus tears in the red/white region with success rates that vary from 57% to 100%. Meniscus repairs that fail in this region usually require subsequent removal, which essentially results in loss of the majority of meniscal function and risk of future disabling osteoarthritis. This study will determine if the addition of platelet rich plasma increases the success rate of complex meniscus repairs of longitudinal, horizontal, or radial tears in the red-white region. The investigators have over two decades of experience with clinical studies of meniscus repairs in patients whose age ranged from 9 to 58 years. Those investigations revealed an average success rate in terms of retention of meniscus tissue of 80%. However, meniscus tears classified as horizontal, radial, double longitudinal, and complex multiplanar had success rates of 71-73% which prompted the need for an adjunct therapeutic measure, such as platelet rich plasma, to increase the healing potential in these cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meniscus repair with PRP | Experimental | Procedure: Meniscus repair with PRPMeniscus repair for tears extending into the red/white region with PRP |
| Meniscus repair without PRP | Active comparator | Procedure: Meniscus repair for red/white tears without PRP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for meniscus repair who provide informed consent to participate
Key exclusion criteria (3 listed)
- Patients scheduled for meniscus repair who refuse to participate
- Presence of a tumor, metastatic disease, active infections, platelet count < 10 5/hl Hgb < 10 g/dl, pregnancy, active breastfeeding, and allergy to Bupivicaine
- Patients with preexisting thrombocytopenia, hypofibrinogenemia, or who are on anti-coagulant therapy, or who have a potential hypersensitivity to bovine products
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 |
|---|---|---|
| Meniscus repair for red/white tears without PRPSame operation as experimental, only without the use of platelet rich plasma. | Procedure or surgery | Meniscus repair without PRP |
| Meniscus repair with PRPMeniscus repair with platelet rich plasma using vertical divergent suture techniques. | Procedure or surgery | Meniscus repair with PRP |
Primary outcome
Elimination of pain
Time frame: Minimum 2 years postoperatively
1 secondary outcome
Magnetic resonance imaging: T2 mapping, signal changes
Time frame: Minimum 2 years postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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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.
Frank R Noyes, M.D. principal investigator
Cincinnati Sportsmedicine Research and Education Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meniscus repair for red/white tears without PRP and Meniscus repair with PRP in people with Cartilage Disease, run by Sue Barber-Westin 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 11 Dec 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
Elimination of pain (time frame: Minimum 2 years postoperatively). 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 Dec 2014.