Early Viscosupplementation After Partial Meniscectomy: a Randomized Controlled Trial
NCT ID: NCT02629380
Last Updated: 2017-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2012-12-31
2016-05-31
Brief Summary
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The aim of the present double blind controlled study was to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of HA performed at the end of arthroscopic partial meniscectomy.
Patients included in this trial were randomized in two treatment groups: the first one received a single injection of HA (Hymovis 24 mg/3ml, Fidia Farmaceutici Spa, Padova, Italy) at the end of the arthroscopic meniscectomy, whereas the second group was treated by surgery alone.
All patients were evaluated basally, at 15, 30, 60, and 180 days after surgery by the following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the operated and contralateral knee were documented; also in addition, the trans-patellar circumference of both knees was registered to assess the trend of knee swelling over time.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Hyaluronic acid group
Single injection of 3 ml HA (Hymovis, Fidia Farmaceutici SpA, Padova, Italy) at the end of the arthroscopic meniscectomy
hyaluronic acid
A single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy
meniscectomy alone
Arthroscopic meniscectomy alone
meniscectomy alone
The patients randomized in this group will receive arthroscopic meniscectomy alone
Interventions
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hyaluronic acid
A single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy
meniscectomy alone
The patients randomized in this group will receive arthroscopic meniscectomy alone
Eligibility Criteria
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Inclusion Criteria
2. healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);
Exclusion Criteria
2. other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries);
3. history of knee infectious arthritis;
4. concurrent rheumatic, metabolic or severe systemic disease;
5. Body Mass Index (BMI) \> 30;
6. known hypersensibility or allergy to/towards HA ;
7. alcohol or other substances abuse/excess.
18 Years
50 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Federica Balboni
BScD
Principal Investigators
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Elizaveta Kon, MD
Role: PRINCIPAL_INVESTIGATOR
II Clinic and Nano-biotechnology Lab, Rizzoli Orthopedic Institute, Bologna, Italy
Locations
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II Orthopaedic Clinic, Rizzoli Orthopaedic Institute
Bologna, Emilia-Romagna, Italy
Countries
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References
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Edouard P, Rannou F, Coudeyre E. Animal evidence for hyaluronic acid efficacy in knee trauma injuries. Review of animal-model studies. Phys Ther Sport. 2013 May;14(2):116-23. doi: 10.1016/j.ptsp.2013.02.001. Epub 2013 Mar 16.
Freymann U, Endres M, Goldmann U, Sittinger M, Kaps C. Toward scaffold-based meniscus repair: effect of human serum, hyaluronic acid and TGF-ss3 on cell recruitment and re-differentiation. Osteoarthritis Cartilage. 2013 May;21(5):773-81. doi: 10.1016/j.joca.2013.02.655. Epub 2013 Mar 5.
Thein R, Haviv B, Kidron A, Bronak S. Intra-articular injection of hyaluronic acid following arthroscopic partial meniscectomy of the knee. Orthopedics. 2010 Oct 11;33(10):724. doi: 10.3928/01477447-20100826-11.
Tan GK, Dinnes DL, Butler LN, Cooper-White JJ. Interactions between meniscal cells and a self assembled biomimetic surface composed of hyaluronic acid, chitosan and meniscal extracellular matrix molecules. Biomaterials. 2010 Aug;31(23):6104-18. doi: 10.1016/j.biomaterials.2010.04.018. Epub 2010 May 14.
Westrich G, Schaefer S, Walcott-Sapp S, Lyman S. Randomized prospective evaluation of adjuvant hyaluronic acid therapy administered after knee arthroscopy. Am J Orthop (Belle Mead NJ). 2009 Dec;38(12):612-6.
Waddell DD, Bert JM. The use of hyaluronan after arthroscopic surgery of the knee. Arthroscopy. 2010 Jan;26(1):105-11. doi: 10.1016/j.arthro.2009.05.009. Epub 2009 Nov 25.
Cake M, Read R, Edwards S, Smith MM, Burkhardt D, Little C, Ghosh P. Changes in gait after bilateral meniscectomy in sheep: effect of two hyaluronan preparations. J Orthop Sci. 2008 Nov;13(6):514-23. doi: 10.1007/s00776-008-1279-6. Epub 2008 Dec 17.
Mathies B. Effects of Viscoseal, a synovial fluid substitute, on recovery after arthroscopic partial meniscectomy and joint lavage. Knee Surg Sports Traumatol Arthrosc. 2006 Jan;14(1):32-9. doi: 10.1007/s00167-005-0625-x. Epub 2005 May 26.
Filardo G, Di Matteo B, Tentoni F, Cavicchioli A, Di Martino A, Lo Presti M, Iacono F, Kon E, Marcacci M. No Effects of Early Viscosupplementation After Arthroscopic Partial Meniscectomy: A Randomized Controlled Trial. Am J Sports Med. 2016 Dec;44(12):3119-3125. doi: 10.1177/0363546516660070. Epub 2016 Aug 15.
Other Identifiers
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Rizzoli HA-MEN
Identifier Type: -
Identifier Source: org_study_id
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