Platelet-Rich Plasma Clinical Trial
— APM-PRPOfficial title:
Arthroscopic Partial Menisectomy or Platelet Rich Plasma in Degenerative Meniscus Without Osteoarthritis? Study Protocol for a Randomized Controlled Trial
This study compares arthroscopic partial menisectomy (APM) and platelet rich plasma (PRP) for degenerative meniscal injury of the knee. The current state of knowledge is poor. There are few comparative studies that have been performed and only on surgical treatment or rehabilitation. Moreover, these studies show contradictory results. The main objective of this study is to compare APM and PRPinfiltration, in terms of pain reduction, which is greater with the surgical technique than in the PRP infiltration group. The hypothesis of this study is that there is superiority of surgery over PRP infiltration. The main evaluation criterion is the pre-post-operative pain by a simplified numerical scale.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | June 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | Inclusion Criteria: - Eligible for APM - Acceptance of infiltration procedure or APM - Patient age above 30 years and under 65 years - Acceptance of outpatient procedure - Non-locked painful knee = 1 month - No osteoarthritis Kellgren-Lawrence = 2 or Alhback = 1 (Monopodal weh-ight-bearing AP and profile X-Ray with the knee in extension and bipedal schuss X-Ray with the knee at 45° of flexion - No malignment > 5° (Full leg standing X-Ray) - Pain when squatting - Medial pain - MRI confirmed unique horizontal degenerative medial lesion Exclusion Criteria: - Traumatic meniscal injury - Neurological or rheumatic inflammatory diseases - MRI : Loose bodies or ligament injuries or osteochondral defects or tumors - Previous ipsilateral knee surgery |
Country | Name | City | State |
---|---|---|---|
France | ICR Clinique Kantys Centre | Nice |
Lead Sponsor | Collaborator |
---|---|
Institut de Chirurgie Reparatrice Locomoteur et Sports |
France,
Aprato A, Sordo L, Costantino A, Sabatini L, Barberis L, Testa D, Massè A. Outcomes at 20 Years After Meniscectomy in Patients Aged 50 to 70 Years. Arthroscopy. 2021 May;37(5):1547-1553. doi: 10.1016/j.arthro.2020.11.053. Epub 2020 Dec 9. — View Citation
Braun HJ, Wasterlain AS, Dragoo JL. The use of PRP in ligament and meniscal healing. Sports Med Arthrosc Rev. 2013 Dec;21(4):206-12. doi: 10.1097/JSA.0000000000000005. Review. — View Citation
Thorlund JB, Hare KB, Lohmander LS. Large increase in arthroscopic meniscus surgery in the middle-aged and older population in Denmark from 2000 to 2011. Acta Orthop. 2014 Jun;85(3):287-92. doi: 10.3109/17453674.2014.919558. Epub 2014 May 6. — View Citation
Vermesan D, Prejbeanu R, Laitin S, Damian G, Deleanu B, Abbinante A, Flace P, Cagiano R. Arthroscopic debridement compared to intra-articular steroids in treating degenerative medial meniscal tears. Eur Rev Med Pharmacol Sci. 2013 Dec;17(23):3192-6. — View Citation
Yim JH, Seon JK, Song EK, Choi JI, Kim MC, Lee KB, Seo HY. A comparative study of meniscectomy and nonoperative treatment for degenerative horizontal tears of the medial meniscus. Am J Sports Med. 2013 Jul;41(7):1565-70. doi: 10.1177/0363546513488518. Epub 2013 May 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric Rating Scale (NRS) | Scale from 0 to 10 to evaluate pain (0 is no pain and 10 is worse pain ever) | 3 months | |
Secondary | Simple Knee Value (SKV) | Scale from 0 to 100 to evaluate the knee function in daily life (0 is no function and 100 is normal function) | Preop, 1 month, 2 months, 3 months, 6 months, 12 months | |
Secondary | Knee injury and Osteoarthritis Outcome Score (KOOS) | To assess the patient's opinion about their knee and associated problems from 0 worse function to 152 best function, also reported to % by dividing by 152 | Preop, 1 month, 2 months, 3 months, 6 months, 12 months | |
Secondary | IKDC score (from International Knee Documentation Committee) | Subjective evaluation of the knee function (from 0 to 100%, 0 is no function and 100 is normal function) | Preop, 1 month, 2 months, 3 months, 6 months, 12 months | |
Secondary | Lysholm Score | Activity of the knee after injuries (scale from 0 to 100 where 0 is no activity and 100 is normal activities | Preop, 3 months, 6 months, 12 months | |
Secondary | Net Promoter Score (NPS) | whether or not the patient recommended the questionnaire used, a scale of 0 (not at all likely) to 10 (very likely) | 3 months, 6 months, 12 months | |
Secondary | Healing meniscus | Healing meniscus on MRI (normal signal intensity of tear on T2-weighted imaging is consider as healed, intermediate, bright, or fluid is not healed) | 6 months | |
Secondary | Osteoarthritis grade (Alhback classification) | Progression of osteoarthritis on X-rays with Alhback classification | 3 months, 6 months, 12 months |
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