The Influence of Hyaluronic Acid Injection Following Knee Arthroscopy

NCT ID: NCT02640144

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2018-04-30

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.

Detailed Description

The use of hyaluronic acid is well known as one of the treatment modalities for knee osteoarthritis (OA) .Arthroscopy is a controversial treatment option for knee OA but in some cases, during knee arthroscopy done for other indication, cartilage damage is noted. This cartilage damage may slower the healing and rehabilitation process after knee arthroscopy. Therefore we will evaluate the influence of hyaluronic acid injection on the healing and rehabilitation process following knee arthroscopy.

All patients will be recruited prior to the arthroscopy. All patients will sign a concent form.Patients will be randomly divided to 2 groups which are the 2 arms of this study - treatment group and control group. All patient will be examined by a senior orthopedic surgeon and will fill the pre operative questionnaires. MRI scan of the operated knee prior for the surgery will be collected and evaluated.Knee arthroscopy will be performed by 2 senior orthopedic surgeons. Data and arthroscopic findings will be collected and documented during surgery. 2 weeks after surgery patients will be evaluated in the hospitals' outpatients clinic. The treatment group will be given a series of 3 injections of Sodium Hyaluronate 1%(ARTHREASE, TM) - one injection per week. The control group will be given a series of 3 injections of placebo (BPS - Buffer Phosphate Solution - the buffer solution of the hyaluronic acid regular injections). The syringes will be blinded to the patients and the physician.

questionnaires will be given at 2 weeks, 6 weeks, 3months and 6 months post operatively

Conditions

Cartilage Damage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment group

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

Group Type: ACTIVE_COMPARATOR

Sodium Hyaluronate 1%

Intervention Type: DRUG

Intra articular knee injection following arthroscopy

Control group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Sodium Hyaluronate 1%

Intra articular knee injection following arthroscopy

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

ARTHREASE; Euflexxa; BPS = Buffer Phosphate Solution

Eligibility Criteria

Inclusion Criteria

• 18 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ziv Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Noam Reshef

Attending Orthopedic Surgeon, Orthopedic Sports specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noam Reshef, MD

Role: PRINCIPAL_INVESTIGATOR

Ziv Medical Center, Zefat, Israel

Central Contacts

Noam Reshef, MD

Role: CONTACT

noamreshefmd@gmail.com

+972-54-5523454

Rinat Elizur, Prod. mnger

Role: CONTACT

+972-54-3009512

References

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.

Reference Type: BACKGROUND

PMID: 24185114 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21047602 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16242361 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20954664 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19539353 (View on PubMed)

Study Documents

Document Type: Study Protocol

Original study protocol is written in Hebrew. protocol is available at the Ziv Medical Center, Institutional Review Board (IRB) , or in direct request via the website address posted above.

View Document

Other Identifiers

0013-15-ZIV

Identifier Type: -

Identifier Source: org_study_id