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Assessment of Outcome of Meniscus Repair With or Without Platelet Rich Plasma

Repair of Human Meniscus Complex Red/White Tears With or Without Platelet-Rich Plasma

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00961597
Enrollment
0
Registered
2009-08-19
Start date
2009-09-30
Completion date
2014-12-31
Last updated
2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage Disease

Keywords

Meniscus, Avascular region, Platelet rich plasma

Brief 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. 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.

Interventions

PROCEDUREMeniscus repair for red/white tears without PRP

Same operation as experimental, only without the use of platelet rich plasma.

PROCEDUREMeniscus repair with PRP

Meniscus repair with platelet rich plasma using vertical divergent suture techniques.

Sponsors

Sue Barber-Westin
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for meniscus repair who provide informed consent to participate

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Elimination of painMinimum 2 years postoperatively

Secondary

MeasureTime frame
Magnetic resonance imaging: T2 mapping, signal changesMinimum 2 years postoperative

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026