Platelet Rich Plasma Study With Meniscal Repair

Meniscus Lesion Clinical Trial

Official title:

Prospective, Double Blind, Randomized Trial: Meniscal Repair With or Without Augmentation Utilizing Platelet Rich Plasma.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01991353
• Other study ID #: 2013-122
• Status: Withdrawn
• Phase: N/A
• First received: November 18, 2013
• Last updated: April 18, 2016
• Start date: July 2015
• Est. completion date: January 2018

Study information

• Verified date: April 2016
• Source: Simon Fraser Orthopaedic Fund
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniscus Lesion

Intervention

Procedure:
• With PRP
Following meniscal repair, PRFM will be delivered arthroscopically into the tear site using a portal skid, arthroscopic canula and arthroscopic atraumatic tissue grasper into the interface of the repair site.
• Without PRP
Standard of care meniscal repair without augmentation.

Locations

Country	Name	City	State
Canada	Eagle Ridge Hospital	Port Moody	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Simon Fraser Orthopaedic Fund

Country where clinical trial is conducted

Canada, 

References & Publications (55)

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* Note: There are 55 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Second look arthroscopy	If a second look arthroscopy is performed, the status of the meniscus (healed or not healed) will be compared to the MRA findings. Second look arthroscopy will be performed on subjects with clinical indication of a failed meniscal repair. Clinical indications of failed meniscus repair include persistent pain and symptoms or MRA positive for a meniscus repair.	if applicable	No
Primary	MRA (magnetic resonance imaging arthrography	The primary outcome measures will be assessment of meniscal healing integrity using magnetic resonance imaging arthrography six months post repair.	6 months	No
Secondary	WOMET - Western Ontario Meniscal Outcome Measure	The WOMET is a disease-specific validated tool designed to evaluate HRQOL (Health Related Quality of Life) in patients with meniscal pathology (meniscal tears or in patients who have undergone meniscal repair or resection). In this subset of patients with meniscal pathology, the WOMET has been found to be reliable, valid and responsive.; The WOMET has 16 items including the domains of physical symptoms, sports/recreation/work/lifestyle, and emotions. It demonstrated adequate content and construct validity when compared with other measures. Test-retest reliability was assessed and was found to be high, with an intraclass correlation coefficient of 0.833.	Baseline, 3 months, 6 months 12 months	No
Secondary	VAS Pain Score - Visual Analog Scale	Pain Visual Analog Scale.	Baseline, Post-op Day 1, 6 weeks	No
Secondary	Range of motion	Knee range of motion measurements.	6 weeks, 3 months, 6 months, 12 months	No
Secondary	Tegner Score	Return to pre injury activity level as measured by the Tegner Score.	Baseline, 3, 6 and 12 months post treatment	No