The Influence of Hyaluronic Acid Injection Following Knee Arthroscopy
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- Change in the knee circumference as a measure for Knee swelling
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Rheumatic disease
- •Synovial disease such as (but not limited to) Pigmented ViloNodular synovitis (PVNS)
- •Infection of the operated knee - new or previous
- •Pregnant women.
研究组 & 干预措施
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
干预措施: Sodium Hyaluronate 1% (Drug)
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
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the knee circumference as a measure for Knee swelling
时间窗: up to 6 month
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.
Subjective description of return to normal activity as described by patients
时间窗: up to 6 months
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.
Pain reduction
时间窗: up to 6 month
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
Change in the Short Form (SF) 12 score as a measure of return to normal activity
时间窗: up to 6 months
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.
Change in the International Knee Documentation Committee (IKDC) score as a measure of Return to normal activity
时间窗: up to 6 month
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
Subjective change in knee swelling
时间窗: up to 6 months
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.
Change in Short Form(SF) 12 score as a measure of better function
时间窗: up to 6 months
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
Change in "Tegner-Lysholm" score as a measure of better function
时间窗: up to 6 month
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
Change in the "Tegner-Lysholm" score as a measure of return to normal activity
时间窗: up to 6 months
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
Change in the International Knee Documentation Committee (IKDC) score as a measure of better function
时间窗: up to 6 months
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
次要结局
未报告次要终点
研究者
Noam Reshef
Attending Orthopedic Surgeon, Orthopedic Sports specialist
Ziv Medical Center