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Platelet Rich Plasma Study With Meniscal Repair

F

Fraser Orthopaedic Research Society

Status

Withdrawn

Conditions

Meniscus Lesion

Treatments

Procedure: Without PRP
Procedure: With PRP

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01991353
2013-122

Details and patient eligibility

About

This study will compare meniscal healing with or without platelet rich plasma. The assessments will include validated, disease specific, patient oriented outcome measures, MRI arthrogram (MRA). Results of this study will help ascertain whether PRP improves meniscal healing rates.

Null Hypothesis: There is no difference in meniscal healing with or without the use of PRP.

Full description

The integrity of the meniscus is pivotal to the distribution of joint reaction forces and shock absorption across the knee and meniscal damage can lead to secondary degenerative joint disease. This has lead to treatments directed towards repairing and preserving the meniscus to alter the progression of joint degeneration. Although success rates of meniscal repair are greater when performed in association with anterior cruciate reconstruction, healing rates remain in the 70-80% range for isolated repairs.

Therefore, techniques such as the use of fibrin clots, trephining and rasping of the tissues, have been incorporated to improve healing results of meniscal repair. There has been a surge of enthusiasm for the use of Platelet Rich Plasma (PRP) to improve healing rates of soft tissue injuries. Therefore, it may be reasonable to surmise that applying blood products, such as thrombin and platelet rich plasma, to the meniscal repair bed may induce more complete and possibly faster healing.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • complete vertical longitudinal tear > 10 mm in length
  • tear located in the vascular portion of the meniscus, classified as either red-red or red-white zones
  • a stable knee, or a knee that is stabilized with a concurrent ACL reconstruction
  • unstable peripheral tear that can be displaced toward center of joint
  • single tear of the medial and/or lateral meniscus
  • skeletally mature patients 18-60 years of age

Exclusion criteria

  • associated significant ligament instability: Grade III MCL, Grade III PCL
  • discoid meniscus
  • ACL deficient knee
  • Outerbridge Grade III or IV cartilage changes on arthroscopy in the involved compartment
  • Significant degenerative changes on radiographs (Kellgren Lawrence >/= Grade III)
  • Associated osteochondral defect that requires treatment
  • Inflammatory arthropathy (e.g. rheumatoid arthritis)
  • Non repairable meniscus (ie white zone, irreducible meniscus)
  • Degenerative meniscus or presence of CPP crystals in meniscus
  • Underlying bleeding disorder or coagulopathy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

With PRP
Experimental group
Description:
Standardized meniscal repair with PRP (platelet rich plasma) in the meniscal healing bed.
Treatment:
Procedure: With PRP
Without PRP
Active Comparator group
Description:
Standardized meniscal repair without PRP (platelet rich plasma).
Treatment:
Procedure: Without PRP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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