Early Viscosupplementation After Partial Meniscectomy: a Randomized Controlled Trial

NCT02629380 | Completed Phase 4 DMC

• 1 other identifier: Rizzoli HA-MEN
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The rational of intra-articular viscosupplementation is based on both the biological and mechanical properties of HA, which exerts positive effects on the modulation of the entire joint environment. 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.

Conditions

Meniscus Lesion

Keywords

meniscectomy; hyaluronic acid; intra-op injection; randomized controlled trial; placebo

Outcome Measures

Primary Outcomes (1)

• Change in IKDC (International Knee Documentation Committee) score

  basal, 15,30,60,180 days

Secondary Outcomes (9)

• Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)

  basal, 15,30,60,180 days

• Change in Tegner Score

  basal, 15,30,60,180 days

• Change in VAS (Visual Analogue Scale) for pain

  basal, 15,30,60,180 days

• Change in EQ-VAS for general health

  basal, 15,30,60,180 days

• Change in transpatellar circumference over time

  basal, 15,30,60,180 days

Study Arms (2)

Hyaluronic acid group

EXPERIMENTAL

Single injection of 3 ml HA (Hymovis, Fidia Farmaceutici SpA, Padova, Italy) at the end of the arthroscopic meniscectomy

Biological: hyaluronic acid

meniscectomy alone

OTHER

Arthroscopic meniscectomy alone

Procedure: meniscectomy alone

Interventions

hyaluronic acid BIOLOGICAL

A single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy

Hyaluronic acid group

meniscectomy alone PROCEDURE

The patients randomized in this group will receive arthroscopic meniscectomy alone

meniscectomy alone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• chronic symptomatic meniscal tears requiring partial resection;
• healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);

You may not qualify if:

• previous surgery on the index knee;
• other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries);
• history of knee infectious arthritis;
• concurrent rheumatic, metabolic or severe systemic disease;
• Body Mass Index (BMI) \> 30;
• known hypersensibility or allergy to/towards HA ;
• alcohol or other substances abuse/excess.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

II Orthopaedic Clinic, Rizzoli Orthopaedic Institute

Bologna, Emilia-Romagna, 40136, Italy

Location

Related Publications (9)

• 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.

  PMID: 23506791 BACKGROUND

• 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.

  PMID: 23473977 BACKGROUND

• 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.

  PMID: 20954664 BACKGROUND

• 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.

  PMID: 20471080 BACKGROUND

• 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.

  PMID: 20145786 BACKGROUND

• 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.

  PMID: 20117634 BACKGROUND

• 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.

  PMID: 19089539 BACKGROUND

• 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.

  PMID: 15918064 BACKGROUND

• 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.

  PMID: 27528611 DERIVED

MeSH Terms

Interventions

Hyaluronic Acid; Meniscectomy

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Elizaveta Kon, MD

  II Clinic and Nano-biotechnology Lab, Rizzoli Orthopedic Institute, Bologna, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BScD

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: December 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)