The Influence of Hyaluronic Acid Injection Following Knee Arthroscopy

Study Overview
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Brief Summary
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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
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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

Official Title
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The Influence of Hyaluronic Acid Injection Following Knee Arthroscopy

Conditions
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Cartilage Damage

Intervention / Treatment
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* Drug: Sodium Hyaluronate 1%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>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%<br>* Intra articular knee injection following arthroscopy<br>* Other names: Euflexxa;|
| Placebo Comparator: Control group<br>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<br>* Intra articular knee injection following knee arthroscopy. Serves as a placebo. This is the actual buffer of the ARTHREASE injection.<br>* Other names: BPS = Buffer Phosphate Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic acid, Knee arthroscopy, pain reduction, swelling, osteoarthritis, cartilage lesion, rehabilitation following knee arthroscopy, Hyaluronic acid injection