Early Viscosupplementation After Partial Meniscectomy: a Randomized Controlled Trial

Meniscus Lesion Clinical Trial

— HA-MEN  

Official title:

Early Viscosupplementation After Partial Meniscectomy: a Double Blind, Placebo Controlled Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629380
• Other study ID #: Rizzoli HA-MEN
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2015
• Last updated: September 12, 2017
• Start date: December 2012
• Est. completion date: May 2016

Study information

• Verified date: September 2017
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. chronic symptomatic meniscal tears requiring partial resection;

2. healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);

Exclusion Criteria:

1. previous surgery on the index knee;

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.

Related Conditions & MeSH terms

• Meniscus Lesion

Intervention

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

Procedure:
• meniscectomy alone
The patients randomized in this group will receive arthroscopic meniscectomy alone

Locations

Country	Name	City	State
Italy	II Orthopaedic Clinic, Rizzoli Orthopaedic Institute	Bologna	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2005 May 26. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IKDC (International Knee Documentation Committee) score		basal, 15,30,60,180 days
Secondary	Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)		basal, 15,30,60,180 days
Secondary	Change in Tegner Score		basal, 15,30,60,180 days
Secondary	Change in VAS (Visual Analogue Scale) for pain		basal, 15,30,60,180 days
Secondary	Change in EQ-VAS for general health		basal, 15,30,60,180 days
Secondary	Change in transpatellar circumference over time		basal, 15,30,60,180 days
Secondary	Change in active and passive ROM		basal, 15,30,60,180 days
Secondary	Adverse events report		15 days
Secondary	Adverse events report		30 days
Secondary	Adverse events report		60 days