The Influence of Hyaluronic Acid Injection Following Knee Arthroscopy

NCT02640144 | Unknown Phase 4

• 1 other identifier: 0013-15-ZIV
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, double blind randomized controlled trial. In this study we will investigate the influence of hyaluronic acid injection to knee after knee arthroscopy, when known or discovered cartilage damage greater than International Cartilage Research Society score (ICRS) grade 2 is found. The indication for arthroscopy is not necessarily the cartilage damage. A set of 3 consecutive injections will be administered and follow up of physical examination and questionaries will be done. Our null hypothesis is that the administration of hyaluronic acid will show decrease pain and quicker rehabilitation and return to normal activity in patients with grade 2 and higher cartilage damage that had gone through knee arthroscopy.

Conditions

Cartilage Damage

Keywords

Hyaluronic acid; Knee arthroscopy; pain reduction; swelling; osteoarthritis; cartilage lesion; rehabilitation following knee arthroscopy; Hyaluronic acid injection

Outcome Measures

Primary Outcomes (10)

• Pain reduction

  The treatment group will show lower scores than control group at all checkpoints- 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Evaluated using Visual Analog Scale (VAS) for pain

  up to 6 month

• Change in the International Knee Documentation Committee (IKDC) score as a measure of Return to normal activity

  The treatment group will show quicker return to normal activity that control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Evaluation is using the International Knee Documentation Committee (IKDC) score

  up to 6 month

• Change in the knee circumference as a measure for Knee swelling

  The treatment group will show less episodes of knee swelling than the control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Will be evaluated by measuring the knee circumference using a simple measuring tape in centimeters.

  up to 6 month

• Change in "Tegner-Lysholm" score as a measure of better function

  The treatment group will show better scores in all functional questionnaires than the control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively.The questionnaires that will be used is "Tegner - Lysholm" score

  up to 6 month

• Change in the Short Form (SF) 12 score as a measure of return to normal activity

  The treatment group will show quicker return to normal activity that control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Evaluation is using Short Form (SF)-12 score.

  up to 6 months

• Subjective description of return to normal activity as described by patients

  The treatment group will show quicker return to normal activity that control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Evaluation is subjective by patients description.

  up to 6 months

• Change in the "Tegner-Lysholm" score as a measure of return to normal activity

  The treatment group will show quicker return to normal activity that control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Evaluation is subjective by using "Tegner - Lysholm" score

  up to 6 months

• Subjective change in knee swelling

  The treatment group will show less episodes of knee swelling than the control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Will be evaluated subjectively by the patients description.

  up to 6 months

• Change in Short Form(SF) 12 score as a measure of better function

  The treatment group will show better scores in all functional questionnaires than the control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively.The questionnaires that will be used is Short-Form (SF)12 score

  up to 6 months

• Change in the International Knee Documentation Committee (IKDC) score as a measure of better function

  The treatment group will show better scores in all functional questionnaires than the control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively.The questionnaires that will be used is International Knee Documentation Committee (IKDC) score

  up to 6 months

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Randomized, patients that are going for knee arthroscopy for any indication including pain and cartilage damage or osteoarthritis. After surgery - will receive 3 injections of Sodium Hyaluronate 1% - ARTHREASE TM

Drug: Sodium Hyaluronate 1%

Control group

PLACEBO COMPARATOR

Randomized, patients that are going for knee arthroscopy for any indication including pain and cartilage damage or osteoarthritis. After surgery - will receive 3 injections of BPS - Buffer Phosphate Solution - as a placebo

Drug: Placebo

Interventions

Sodium Hyaluronate 1% DRUG

Intra articular knee injection following arthroscopy

Also known as: ARTHREASE, Euflexxa

Treatment group

Placebo DRUG

Intra articular knee injection following knee arthroscopy. Serves as a placebo. This is the actual buffer of the ARTHREASE injection.

Also known as: BPS = Buffer Phosphate Solution

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• signing a concent form
• Assigned for knee arthroscopy.
• Known chondral lesion of at least ICRS grade 2 in one or mor of the knee compartments per MRI prior to knee arthroscopy.
• Cartilage lesion of at least ICRS grade 2 in one or mor of the knee compartments that was found during the knee arthroscopy.

You may not qualify if:

• Rheumatic disease
• Synovial disease such as (but not limited to) Pigmented ViloNodular synovitis (PVNS)
• Infection of the operated knee - new or previous
• Pregnant women.

Sponsors & Collaborators

• Ziv Medical Center: lead

Related Publications (5)

• Leighton R, Akermark C, Therrien R, Richardson JB, Andersson M, Todman MG, Arden NK; DUROLANE Study Group. NASHA hyaluronic acid vs. methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014 Jan;22(1):17-25. doi: 10.1016/j.joca.2013.10.009. Epub 2013 Nov 1.

  PMID: 24185114 BACKGROUND

• Witteveen AG, Sierevelt IN, Blankevoort L, Kerkhoffs GM, van Dijk CN. Intra-articular sodium hyaluronate injections in the osteoarthritic ankle joint: effects, safety and dose dependency. Foot Ankle Surg. 2010 Dec;16(4):159-63. doi: 10.1016/j.fas.2009.10.003. Epub 2009 Nov 8.

  PMID: 21047602 BACKGROUND

• Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2006 Feb;14(2):154-62. doi: 10.1016/j.joca.2005.09.003. Epub 2005 Oct 19.

  PMID: 16242361 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 RESULT

• Altman RD, Rosen JE, Bloch DA, Hatoum HT, Korner P. A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial). Semin Arthritis Rheum. 2009 Aug;39(1):1-9. doi: 10.1016/j.semarthrit.2009.04.001. Epub 2009 Jun 17.

  PMID: 19539353 RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Noam Reshef, MD

  Ziv Medical Center, Zefat, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noam Reshef, MD

CONTACT

+972-54-5523454; noamreshefmd@gmail.com

Rinat Elizur, Prod. mnger

CONTACT

+972-54-3009512

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Orthopedic Surgeon, Orthopedic Sports specialist

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 28, 2015
• Study Start: February 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 25, 2017

Record last verified: 2017-01