NCT01991353

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

2 years

First QC Date

November 18, 2013

Last Update Submit

April 18, 2016

Conditions

Meniscus Lesion

Keywords

Kneemeniscusplatelet rich plasma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • WOMET - Western Ontario Meniscal Outcome Measure

    Baseline, 3 months, 6 months 12 months

  • VAS Pain Score - Visual Analog Scale

    Baseline, Post-op Day 1, 6 weeks

  • Range of motion

    6 weeks, 3 months, 6 months, 12 months

  • Tegner Score

    Baseline, 3, 6 and 12 months post treatment

Other Outcomes (1)

  • Second look arthroscopy

    if applicable

Study Arms (2)

With PRP

EXPERIMENTAL

Standardized meniscal repair with PRP (platelet rich plasma) in the meniscal healing bed.

Procedure: With PRP

Without PRP

ACTIVE COMPARATOR

Standardized meniscal repair without PRP (platelet rich plasma).

Procedure: Without PRP

Interventions

With PRPPROCEDURE

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.

Also known as: Platelet Rich Fibrin Matrix (PRFM)
With PRP
Without PRPPROCEDURE

Standard of care meniscal repair without augmentation.

Without PRP

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eagle Ridge Hospital

Port Moody, British Columbia, V3H 3W9, Canada

Location

Related Publications (55)

  • Andersson-Molina H, Karlsson H, Rockborn P. Arthroscopic partial and total meniscectomy: A long-term follow-up study with matched controls. Arthroscopy. 2002 Feb;18(2):183-9. doi: 10.1053/jars.2002.30435.

    PMID: 11830813RESULT

  • Johnson RJ, Kettelkamp DB, Clark W, Leaverton P. Factors effecting late results after meniscectomy. J Bone Joint Surg Am. 1974 Jun;56(4):719-29. No abstract available.

    PMID: 4406907RESULT

  • Greis PE, Holmstrom MC, Bardana DD, Burks RT. Meniscal injury: II. Management. J Am Acad Orthop Surg. 2002 May-Jun;10(3):177-87. doi: 10.5435/00124635-200205000-00004.

    PMID: 12041939RESULT

  • Lietman SA, Hobbs W, Inoue N, Reddi AH. Effects of selected growth factors on porcine meniscus in chemically defined medium. Orthopedics. 2003 Aug;26(8):799-803. doi: 10.3928/0147-7447-20030801-19.

    PMID: 12938945RESULT

  • Sethi PM, Cooper A, Jokl P. Technical tips in orthopaedics: meniscal repair with use of an in situ fibrin clot. Arthroscopy. 2003 May-Jun;19(5):E44. doi: 10.1053/jars.2003.50164.

    PMID: 12724668RESULT

  • Henning CE, Lynch MA, Yearout KM, Vequist SW, Stallbaumer RJ, Decker KA. Arthroscopic meniscal repair using an exogenous fibrin clot. Clin Orthop Relat Res. 1990 Mar;(252):64-72.

    PMID: 2406075RESULT

  • Henning CE, Yearout KM, Vequist SW, Stallbaumer RJ, Decker KA. Use of the fascia sheath coverage and exogenous fibrin clot in the treatment of complex meniscal tears. Am J Sports Med. 1991 Nov-Dec;19(6):626-31. doi: 10.1177/036354659101900613.

    PMID: 1781502RESULT

  • van Trommel MF, Simonian PT, Potter HG, Wickiewicz TL. Arthroscopic meniscal repair with fibrin clot of complete radial tears of the lateral meniscus in the avascular zone. Arthroscopy. 1998 May-Jun;14(4):360-5. doi: 10.1016/s0749-8063(98)70002-7.

    PMID: 9620646RESULT

  • Voloshin AS, Wosk J. Shock absorption of meniscectomized and painful knees: a comparative in vivo study. J Biomed Eng. 1983 Apr;5(2):157-61. doi: 10.1016/0141-5425(83)90036-5.

    PMID: 6687914RESULT

  • Walker PS, Erkman MJ. The role of the menisci in force transmission across the knee. Clin Orthop Relat Res. 1975;(109):184-92. doi: 10.1097/00003086-197506000-00027.

    PMID: 1173360RESULT

  • Kettelkamp DB, Jacobs AW. Tibiofemoral contact area--determination and implications. J Bone Joint Surg Am. 1972 Mar;54(2):349-56. No abstract available.

    PMID: 4678847RESULT

  • Fukubayashi T, Kurosawa H. The contact area and pressure distribution pattern of the knee. A study of normal and osteoarthrotic knee joints. Acta Orthop Scand. 1980 Dec;51(6):871-9. doi: 10.3109/17453678008990887.

    PMID: 6894212RESULT

  • Cox JS, Nye CE, Schaefer WW, Woodstein IJ. The degenerative effects of partial and total resection of the medial meniscus in dogs' knees. Clin Orthop Relat Res. 1975;(109):178-83. doi: 10.1097/00003086-197506000-00026.

    PMID: 1173359RESULT

  • Rangger C, Klestil T, Gloetzer W, Kemmler G, Benedetto KP. Osteoarthritis after arthroscopic partial meniscectomy. Am J Sports Med. 1995 Mar-Apr;23(2):240-4. doi: 10.1177/036354659502300219.

    PMID: 7778712RESULT

  • McDermott ID, Amis AA. The consequences of meniscectomy. J Bone Joint Surg Br. 2006 Dec;88(12):1549-56. doi: 10.1302/0301-620X.88B12.18140.

    PMID: 17159163RESULT

  • FAIRBANK TJ. Knee joint changes after meniscectomy. J Bone Joint Surg Br. 1948 Nov;30B(4):664-70. No abstract available.

    PMID: 18894618RESULT

  • Fauno P, Nielsen AB. Arthroscopic partial meniscectomy: a long-term follow-up. Arthroscopy. 1992;8(3):345-9. doi: 10.1016/0749-8063(92)90066-k.

    PMID: 1418207RESULT

  • DeHaven KE, Black KP, Griffiths HJ. Open meniscus repair. Technique and two to nine year results. Am J Sports Med. 1989 Nov-Dec;17(6):788-95. doi: 10.1177/036354658901700612.

    PMID: 2696377RESULT

  • DeHaven KE. Meniscus repair. Am J Sports Med. 1999 Mar-Apr;27(2):242-50. doi: 10.1177/03635465990270022301. No abstract available.

    PMID: 10102109RESULT

  • DeHaven KE, Lohrer WA, Lovelock JE. Long-term results of open meniscal repair. Am J Sports Med. 1995 Sep-Oct;23(5):524-30. doi: 10.1177/036354659502300502.

    PMID: 8526265RESULT

  • Rodeo SA. Arthroscopic meniscal repair with use of the outside-in technique. Instr Course Lect. 2000;49:195-206.

    PMID: 10829175RESULT

  • Toman CV, Dunn WR, Spindler KP, Amendola A, Andrish JT, Bergfeld JA, Flanigan D, Jones MH, Kaeding CC, Marx RG, Matava MJ, McCarty EC, Parker RD, Wolcott M, Vidal A, Wolf BR, Huston LJ, Harrell FE Jr, Wright RW. Success of meniscal repair at anterior cruciate ligament reconstruction. Am J Sports Med. 2009 Jun;37(6):1111-5. doi: 10.1177/0363546509337010.

    PMID: 19465734RESULT

  • Horibe S, Shino K, Nakata K, Maeda A, Nakamura N, Matsumoto N. Second-look arthroscopy after meniscal repair. Review of 132 menisci repaired by an arthroscopic inside-out technique. J Bone Joint Surg Br. 1995 Mar;77(2):245-9.

    PMID: 7706339RESULT

  • Horibe S, Shino K, Maeda A, Nakamura N, Matsumoto N, Ochi T. Results of isolated meniscal repair evaluated by second-look arthroscopy. Arthroscopy. 1996 Apr;12(2):150-5. doi: 10.1016/s0749-8063(96)90003-1.

    PMID: 8776990RESULT

  • Logan M, Watts M, Owen J, Myers P. Meniscal repair in the elite athlete: results of 45 repairs with a minimum 5-year follow-up. Am J Sports Med. 2009 Jun;37(6):1131-4. doi: 10.1177/0363546508330138. Epub 2009 Mar 11.

    PMID: 19279222RESULT

  • White LM, Schweitzer ME, Weishaupt D, Kramer J, Davis A, Marks PH. Diagnosis of recurrent meniscal tears: prospective evaluation of conventional MR imaging, indirect MR arthrography, and direct MR arthrography. Radiology. 2002 Feb;222(2):421-9. doi: 10.1148/radiol.2222010396.

    PMID: 11818609RESULT

  • Ciliz D, Ciliz A, Elverici E, Sakman B, Yuksel E, Akbulut O. Evaluation of postoperative menisci with MR arthrography and routine conventional MRI. Clin Imaging. 2008 May-Jun;32(3):212-9. doi: 10.1016/j.clinimag.2007.09.008.

    PMID: 18502349RESULT

  • Vives MJ, Homesley D, Ciccotti MG, Schweitzer ME. Evaluation of recurring meniscal tears with gadolinium-enhanced magnetic resonance imaging: a randomized, prospective study. Am J Sports Med. 2003 Nov-Dec;31(6):868-73. doi: 10.1177/03635465030310062301.

    PMID: 14623651RESULT

  • Elentuck D, Palmer WE. Direct magnetic resonance arthrography. Eur Radiol. 2004 Nov;14(11):1956-67. doi: 10.1007/s00330-004-2449-3. Epub 2004 Sep 3.

    PMID: 15351900RESULT

  • Schulte-Altedorneburg G, Gebhard M, Wohlgemuth WA, Fischer W, Zentner J, Wegener R, Balzer T, Bohndorf K. MR arthrography: pharmacology, efficacy and safety in clinical trials. Skeletal Radiol. 2003 Jan;32(1):1-12. doi: 10.1007/s00256-002-0595-8. Epub 2002 Dec 5.

    PMID: 12525938RESULT

  • Quinn SF, Brown TF. Meniscal tears diagnosed with MR imaging versus arthroscopy: how reliable a standard is arthroscopy? Radiology. 1991 Dec;181(3):843-7. doi: 10.1148/radiology.181.3.1947108.

    PMID: 1947108RESULT

  • Deutsch AL, Mink JH, Fox JM, Arnoczky SP, Rothman BJ, Stoller DW, Cannon WD Jr. Peripheral meniscal tears: MR findings after conservative treatment or arthroscopic repair. Radiology. 1990 Aug;176(2):485-8. doi: 10.1148/radiology.176.2.2367665.

    PMID: 2367665RESULT

  • De Smet AA, Norris MA, Yandow DR, Quintana FA, Graf BK, Keene JS. MR diagnosis of meniscal tears of the knee: importance of high signal in the meniscus that extends to the surface. AJR Am J Roentgenol. 1993 Jul;161(1):101-7. doi: 10.2214/ajr.161.1.8517286.

    PMID: 8517286RESULT

  • Haims AH, Katz LD, Ruwe PA. MR Arthrography of the Knee. Semin Musculoskelet Radiol. 1998;2(4):385-396. doi: 10.1055/s-2008-1080119.

    PMID: 11387117RESULT

  • Cardello P, Gigli C, Ricci A, Chiatti L, Voglino N, Pofi E. Retears of postoperative knee meniscus: findings on magnetic resonance imaging (MRI) and magnetic resonance arthrography (MRA) by using low and high field magnets. Skeletal Radiol. 2009 Feb;38(2):149-56. doi: 10.1007/s00256-008-0600-y. Epub 2008 Oct 10.

    PMID: 18846372RESULT

  • Gopez AG, Kavanagh EC. MR imaging of the postoperative meniscus: repair, resection, and replacement. Semin Musculoskelet Radiol. 2006 Sep;10(3):229-40. doi: 10.1055/s-2006-957176.

    PMID: 17195131RESULT

  • Muellner T, Egkher A, Nikolic A, Funovics M, Metz V. Open meniscal repair: clinical and magnetic resonance imaging findings after twelve years. Am J Sports Med. 1999 Jan-Feb;27(1):16-20. doi: 10.1177/03635465990270011001.

    PMID: 9934413RESULT

  • White LM, Kramer J, Recht MP. MR imaging evaluation of the postoperative knee: ligaments, menisci, and articular cartilage. Skeletal Radiol. 2005 Aug;34(8):431-52. doi: 10.1007/s00256-005-0914-y. Epub 2005 Jun 21.

    PMID: 15968555RESULT

  • Mustonen AO, Tielinen L, Lindahl J, Hirvensalo E, Kiuru M, Koskinen SK. MRI of menisci repaired with bioabsorbable arrows. Skeletal Radiol. 2006 Jul;35(7):515-21. doi: 10.1007/s00256-006-0080-x. Epub 2006 Mar 18.

    PMID: 16547748RESULT

  • Scott GA, Jolly BL, Henning CE. Combined posterior incision and arthroscopic intra-articular repair of the meniscus. An examination of factors affecting healing. J Bone Joint Surg Am. 1986 Jul;68(6):847-61.

    PMID: 3755440RESULT

  • Arnoczky SP, Cooper TG, Stadelmaier DM, Hannafin JA. Magnetic resonance signals in healing menisci: an experimental study in dogs. Arthroscopy. 1994 Oct;10(5):552-7. doi: 10.1016/s0749-8063(05)80013-1.

    PMID: 7999166RESULT

  • Arnoczky SP, Warren RF. The microvasculature of the meniscus and its response to injury. An experimental study in the dog. Am J Sports Med. 1983 May-Jun;11(3):131-41. doi: 10.1177/036354658301100305.

    PMID: 6688156RESULT

  • Applegate GR, Flannigan BD, Tolin BS, Fox JM, Del Pizzo W. MR diagnosis of recurrent tears in the knee: value of intraarticular contrast material. AJR Am J Roentgenol. 1993 Oct;161(4):821-5. doi: 10.2214/ajr.161.4.8372768.

    PMID: 8372768RESULT

  • Wojtys EM, Chan DB. Meniscus structure and function. Instr Course Lect. 2005;54:323-30.

    PMID: 15948460RESULT

  • Hashimoto J, Kurosaka M, Yoshiya S, Hirohata K. Meniscal repair using fibrin sealant and endothelial cell growth factor. An experimental study in dogs. Am J Sports Med. 1992 Sep-Oct;20(5):537-41. doi: 10.1177/036354659202000509.

    PMID: 1443321RESULT

  • Cole BJ, Seroyer ST, Filardo G, Bajaj S, Fortier LA. Platelet-rich plasma: where are we now and where are we going? Sports Health. 2010 May;2(3):203-10. doi: 10.1177/1941738110366385.

    PMID: 23015939RESULT

  • Lopez-Vidriero E, Goulding KA, Simon DA, Sanchez M, Johnson DH. The use of platelet-rich plasma in arthroscopy and sports medicine: optimizing the healing environment. Arthroscopy. 2010 Feb;26(2):269-78. doi: 10.1016/j.arthro.2009.11.015.

    PMID: 20141991RESULT

  • Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plast Reconstr Surg. 2004 Nov;114(6):1502-8. doi: 10.1097/01.prs.0000138251.07040.51.

    PMID: 15509939RESULT

  • Fufa D, Shealy B, Jacobson M, Kevy S, Murray MM. Activation of platelet-rich plasma using soluble type I collagen. J Oral Maxillofac Surg. 2008 Apr;66(4):684-90. doi: 10.1016/j.joms.2007.06.635.

    PMID: 18355591RESULT

  • Scordino LE, Deberardino TM. Biologic enhancement of meniscus repair. Clin Sports Med. 2012 Jan;31(1):91-100. doi: 10.1016/j.csm.2011.09.001. No abstract available.

    PMID: 22108661RESULT

  • Tumia NS, Johnstone AJ. Platelet derived growth factor-AB enhances knee meniscal cell activity in vitro. Knee. 2009 Jan;16(1):73-6. doi: 10.1016/j.knee.2008.08.008. Epub 2008 Oct 30.

    PMID: 18976925RESULT

  • Ishida K, Kuroda R, Miwa M, Tabata Y, Hokugo A, Kawamoto T, Sasaki K, Doita M, Kurosaka M. The regenerative effects of platelet-rich plasma on meniscal cells in vitro and its in vivo application with biodegradable gelatin hydrogel. Tissue Eng. 2007 May;13(5):1103-12. doi: 10.1089/ten.2006.0193.

    PMID: 17348798RESULT

  • de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986.

    PMID: 20068208RESULT

  • Benko A, Fraser-Hill M, Magner P, Capusten B, Barrett B, Myers A, Owen RJ; Canadian Association of Radiologists. Canadian Association of Radiologists: consensus guidelines for the prevention of contrast-induced nephropathy. Can Assoc Radiol J. 2007 Apr;58(2):79-87.

    PMID: 17521052RESULT

  • Kirkley A, Griffin S, Whelan D. The development and validation of a quality of life-measurement tool for patients with meniscal pathology: the Western Ontario Meniscal Evaluation Tool (WOMET). Clin J Sport Med. 2007 Sep;17(5):349-56. doi: 10.1097/JSM.0b013e31814c3e15.

    PMID: 17873546RESULT

Study Officials

  • Robert G. McCormack, MD, FRCSC

    Simon Fraser Orthopaedic Fund / Fraser Health Authority / University of British Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 25, 2013

Study Start

July 1, 2015

Primary Completion

July 1, 2017

Study Completion

January 1, 2018

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

CA(1)