Meniscus LesionNCT01991353
Platelet Rich Plasma Study With Meniscal Repair
A study testing With PRP and Without PRP in people with Meniscus Lesion, run by Fraser Orthopaedic Research Society at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Meniscus Lesion
- What is being tested?
- With PRP and Without 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 siteCanada
- Study dates
- Jul 2015to Jan 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Double Blind, Randomized Trial: Meniscal Repair With or Without Augmentation Utilizing Platelet Rich Plasma.
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.
Read the detailed 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.
- Conditions
- Meniscus Lesion
- Being tested
- With PRP, Without PRP
- Keywords
- Knee, meniscus, platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With PRPProcedure or surgery
Also called Platelet Rich Fibrin Matrix (PRFM)
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 PRPProcedure or surgery
Standard of care meniscal repair without augmentation.
| Study group | Role | What they receive |
|---|---|---|
| With PRP | Experimental | Standardized meniscal repair with PRP (platelet rich plasma) in the meniscal healing bed. Receives: Procedure: With PRP |
| Without PRP | Active comparator | Standardized meniscal repair without PRP (platelet rich plasma). Receives: Procedure: Without PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: Baseline, 3 months, 6 months 12 months
VAS Pain Score - Visual Analog Scale
Pain Visual Analog Scale.
Measured: Baseline, Post-op Day 1, 6 weeks
Range of motion
Knee range of motion measurements.
Measured: 6 weeks, 3 months, 6 months, 12 months
Tegner Score
Return to pre injury activity level as measured by the Tegner Score.
Measured: Baseline, 3, 6 and 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJul 2015
- Primary completionJul 2017 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for Meniscus LesionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Orthopaedic Research Society
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Robert G. McCormack, MD, FRCSC, Principal investigator, Simon Fraser Orthopaedic Fund / Fraser Health Authority / University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991353
- Sponsor's protocol ID
- 2013-122
- Status last verified
- Apr 2016
- First submitted
- 18 Nov 2013
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11830813Johnson 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.
PubMed 4406907Greis 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.
PubMed 12041939Lietman 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.
PubMed 12938945Sethi 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.
PubMed 12724668Henning 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.
PubMed 2406075Henning 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.
PubMed 1781502van 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.
PubMed 9620646Voloshin 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.
PubMed 6687914Walker 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.
PubMed 1173360Kettelkamp DB, Jacobs AW. Tibiofemoral contact area--determination and implications. J Bone Joint Surg Am. 1972 Mar;54(2):349-56. No abstract available.
PubMed 4678847Fukubayashi 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.
PubMed 6894212Cox 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.
PubMed 1173359Rangger 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.
PubMed 7778712McDermott 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.
PubMed 17159163
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double Blind, Randomized Trial: Meniscal Repair With or Without Augmentation Utilizing Platelet Rich Plasma.
- ClinicalTrials.gov ID
- NCT01991353
- Acronym / sponsor ID
- 2013-122
- Conditions
- Meniscus Lesion
- Keywords
- Knee, meniscus, platelet rich plasma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fraser Orthopaedic Research SocietyResearch network
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 25 Nov 2013 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With PRP | Experimental | Procedure: With PRPStandardized meniscal repair with PRP (platelet rich plasma) in the meniscal healing bed. |
| Without PRP | Active comparator | Procedure: Without PRPStandardized meniscal repair without PRP (platelet rich plasma). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| With PRPAlso: Platelet Rich Fibrin Matrix (PRFM)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. | Procedure or surgery | With PRP |
| Without PRPStandard of care meniscal repair without augmentation. | Procedure or surgery | Without PRP |
Primary outcome
MRA (magnetic resonance imaging arthrography
Time frame: 6 months
The primary outcome measures will be assessment of meniscal healing integrity using magnetic resonance imaging arthrography six months post repair.
4 secondary outcomes
WOMET - Western Ontario Meniscal Outcome Measure
Time frame: Baseline, 3 months, 6 months 12 months
VAS Pain Score - Visual Analog Scale
Time frame: Baseline, Post-op Day 1, 6 weeks
Range of motion
Time frame: 6 weeks, 3 months, 6 months, 12 months
Tegner Score
Time frame: Baseline, 3, 6 and 12 months post treatment
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 19 Apr 2016.
- Results publication: PubMed 11830813Andersson-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.
- Results publication: PubMed 4406907Johnson 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.
- Results publication: PubMed 12041939Greis 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.
- Results publication: PubMed 12938945Lietman 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.
- Results publication: PubMed 12724668Sethi 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.
- Results publication: PubMed 2406075Henning 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.
- Results publication: PubMed 1781502Henning 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.
- Results publication: PubMed 9620646van 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.
- Results publication: PubMed 6687914Voloshin 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.
- Results publication: PubMed 1173360Walker 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.
- Results publication: PubMed 4678847Kettelkamp DB, Jacobs AW. Tibiofemoral contact area--determination and implications. J Bone Joint Surg Am. 1972 Mar;54(2):349-56. No abstract available.
- Results publication: PubMed 6894212Fukubayashi 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.
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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.
Robert G. McCormack, MD, FRCSC principal investigator
Simon Fraser Orthopaedic Fund / Fraser Health Authority / University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With PRP and Without PRP in people with Meniscus Lesion, run by Fraser Orthopaedic Research Society at 1 site in Canada.
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 6 inclusion and 10 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 19 Apr 2016. 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 Canada. 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?
MRA (magnetic resonance imaging arthrography (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01991353, which also lists 55 linked publications.
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 19 Apr 2016.