Clinical trial NCT02640144: The Influence of Hyaluronic Acid Injection Following Knee Arthroscopy
Official title: The Influence of Hyaluronic Acid Injection Following Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cartilage Damage
Keywords: Hyaluronic acid
Knee arthroscopy
pain reduction
swelling
osteoarthritis
cartilage lesion
rehabilitation following knee arthroscopy
Hyaluronic acid injection
Lead sponsor: Ziv Medical Center
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Pain reduction
timeFrame: up to 6 month
measure: Change in the International Knee Documentation Committee (IKDC) score as a measure of Return to normal activity
timeFrame: up to 6 month
measure: Change in the knee circumference as a measure for Knee swelling
timeFrame: up to 6 month
measure: Change in "Tegner-Lysholm" score as a measure of better function
timeFrame: up to 6 month
measure: Change in the Short Form (SF) 12 score as a measure of return to normal activity
timeFrame: up to 6 months
measure: Subjective description of return to normal activity as described by patients
timeFrame: up to 6 months
measure: Change in the "Tegner-Lysholm" score as a measure of return to normal activity
timeFrame: up to 6 months
measure: Subjective change in knee swelling
timeFrame: up to 6 months
measure: Change in Short Form(SF) 12 score as a measure of better function
timeFrame: up to 6 months
measure: Change in the International Knee Documentation Committee (IKDC) score as a measure of better function
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ziv Medical Center, Zefat, Israel
name: Noam Reshef, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.