"Intra-articular Hyaluronic Acid Injection Significantly Accelerates Functional Recovery After Knee Arthroscopy: A Prospective Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total Score
研究概览
简要总结
This study evaluates the effectiveness of intra-articular hyaluronic acid (HA) viscosupplementation and oral chondroitin sulfate (CS) supplementation, in combination with standard postoperative rehabilitation, on functional recovery, pain reduction, and quality of life following knee arthroscopy for medial meniscus injury. Knee arthroscopy is commonly performed for meniscal tears, but the extensive joint irrigation during the procedure removes naturally occurring synovial fluid, potentially prolonging recovery. Hyaluronic acid is the main component of synovial fluid and plays crucial roles in joint lubrication, shock absorption, and cartilage protection. This prospective, randomized, three-arm controlled trial will enroll approximately 290 patients undergoing arthroscopy for medial meniscus injury. Participants will be randomized into three groups: (1) standard rehabilitation alone (Control), (2) rehabilitation plus oral CS supplementation (1200mg CS and 40mg Vitamin C daily for 12 weeks), or (3) rehabilitation plus two intra-articular HA injections (Biolevox™ HA 2.2%, administered at 2 weeks and 6 weeks post-arthroscopy). The primary outcome is knee function assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 weeks. Secondary outcomes include quality of life (WHOQoL-BREF questionnaire) and safety assessments. The study hypothesis is that viscosupplementation with medium molecular weight HA will result in superior functional outcomes compared with oral supplementation or standard rehabilitation alone.
详细描述
Knee arthroscopy is the most commonly performed orthopedic procedure. Although it offers advantages over open surgery, including reduced postoperative pain and faster recovery, the procedure inevitably involves extensive joint irrigation which removes naturally occurring synovial fluid. Synovial fluid plays a crucial role in joint lubrication and shock absorption. Its reduction following arthroscopy increases friction between articular surfaces, intensifying pain and potentially prolonging rehabilitation. Recovery typically requires 4-6 weeks, during which patients may experience persistent pain and limited joint function. Viscosupplementation with hyaluronic acid (HA) has emerged as a promising approach to addressing post-arthroscopic joint dysfunction. HA is the main non-protein component of synovial fluid, forming a protective layer on articular cartilage, reducing friction and helping maintain tissue resistance to compressive forces. Beyond mechanical effects, HA provides biological benefits including stimulation of endogenous HA synthesis, reduction of proteoglycan loss, and protection of chondrocytes from apoptosis. Oral chondroitin sulfate (CS) supplementation has also been proposed as an adjunctive therapy, with proposed mechanisms including support for cartilage homeostasis through stimulation of proteoglycan and collagen synthesis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years at time of enrollment
- •Scheduled for knee arthroscopy for treatment of medial meniscus injury
- •Torn medial meniscus with various morphology confirmed by magnetic resonance imaging (MRI)
- •Positive clinical examination findings specific for medial meniscus tear OR mechanical symptoms (locking, catching)
- •Failed conservative treatment for at least 3 months including physical therapy and/or anti-inflammatory medications
- •Grade 0 or Grade 1 osteoarthritis according to Kellgren-Lawrence radiographic classification scale at baseline visit
- •Able and willing to provide written informed consent
- •Able to comply with study procedures and attend all follow-up visits
- •Willing to adhere to postoperative rehabilitation protocol
排除标准
- •Prior surgery on the ipsilateral knee (except previous knee arthroscopy for partial meniscectomy and/or chondroplasty)
- •Prior surgery on the contralateral knee (except previous knee arthroscopy for partial meniscectomy and/or chondroplasty)
- •Intraoperative diagnosis of anterior cruciate ligament (ACL) injury requiring reconstruction
- •History of concomitant knee procedures including: ligamentous repair or reconstruction, high tibial osteotomy, distal femoral osteotomy, hardware removal, irrigation and debridement for infection, microfracture procedures, autologous chondrocyte implantation (ACI), osteochondral autograft transfer (OATS), or osteochondral allograft transfer
- •Axial knee deformity (varus or valgus malalignment)
- •Radiological signs of knee osteoarthritis Grade 2 or higher on Kellgren-Lawrence scale
- •Inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, etc.)
- •History of septic arthritis in either knee
- •Known hypersensitivity or allergy to hyaluronic acid products, chondroitin sulfate, or any study product components
- •Active infection or skin disease at the injection site
- •Bleeding disorders or current anticoagulation therapy that cannot be safely interrupted
- •Pregnancy or lactation - Current participation in another interventional clinical trial
- •Any condition that, in the opinion of the investigator, would compromise the participant's ability to participate in the study or potentially confound study results
研究组 & 干预措施
Control - Standard Rehabilitation
Participants receive standard postoperative rehabilitation protocol over 12 weeks consisting of four sequential phases: Phase I (weeks 0-3) - joint protection, partial weight-bearing with brace and crutches, swelling management, patellar mobilization, knee ROM exercises 0-90°, quadriceps isometric exercises, straight-leg raises; Phase II (weeks 3-6) - partial weight-bearing continuation, progressive ROM restoration using stationary bicycle, calf strengthening, balance training; Phase III (weeks 6-9) - full weight-bearing progression once adequate quadriceps control achieved, progressive strengthening exercises (partial squats 0-60° knee flexion, hamstring strengthening), cardiovascular conditioning; Phase IV (weeks 9-12) - advanced functional strengthening including lunges, step-based exercises, single-leg progressions.
干预措施: Standard Postoperative Rehabilitation Protocol (Behavioral)
Oral Chondroitin Sulfate Supplementation
Participants receive standard postoperative rehabilitation protocol (identical to Control arm) PLUS oral chondroitin sulfate supplementation (Flextrum: 1200mg chondroitin sulfate and 40mg Vitamin C) taken daily for 12 weeks.
干预措施: Standard Postoperative Rehabilitation Protocol (Behavioral)
Oral Chondroitin Sulfate Supplementation
Participants receive standard postoperative rehabilitation protocol (identical to Control arm) PLUS oral chondroitin sulfate supplementation (Flextrum: 1200mg chondroitin sulfate and 40mg Vitamin C) taken daily for 12 weeks.
干预措施: Oral Chondroitin Sulfate (Flextrum) (Dietary Supplement)
Intra-articular Hyaluronic Acid Viscosupplementation
Participants receive standard postoperative rehabilitation protocol (identical to Control arm) PLUS two intra-articular hyaluronic acid injections (Biolevox™ HA 2.2%, concentration 22mg/mL, volume 2mL, molecular weight 1400-2400 kDa) administered at 2 weeks and 6 weeks post-arthroscopy. Injections are performed under real-time ultrasound guidance using a lateral mid-patellar portal with the knee in full extension, administered by a single certified orthopedic physician.
干预措施: Standard Postoperative Rehabilitation Protocol (Behavioral)
Intra-articular Hyaluronic Acid Viscosupplementation
Participants receive standard postoperative rehabilitation protocol (identical to Control arm) PLUS two intra-articular hyaluronic acid injections (Biolevox™ HA 2.2%, concentration 22mg/mL, volume 2mL, molecular weight 1400-2400 kDa) administered at 2 weeks and 6 weeks post-arthroscopy. Injections are performed under real-time ultrasound guidance using a lateral mid-patellar portal with the knee in full extension, administered by a single certified orthopedic physician.
干预措施: ntra-articular Hyaluronic Acid Injection (Biolevox) (Device)
结局指标
主要结局
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total Score
时间窗: Baseline (pre-surgery) and 12 weeks post-arthroscopy
The KOOS is a validated 42-item patient-reported outcome measure evaluating five domains: Pain (9 items), Other Symptoms (7 items), Function in Daily Living (17 items), Function in Sport and Recreation (5 items), and Knee-related Quality of Life (4 items). Each item is scored on a 0-4 Likert scale. Scores are transformed to 0-100 scale, where 0 represents extreme knee problems, and 100 represents no knee problems. The KOOS Total Score is calculated as the average of all five domain scores. Higher scores indicate better outcomes.
次要结局
- Change in KOOS Pain Subscale Score(Baseline (pre-surgery) and 12 weeks post-arthroscopy)
- Change in World Health Organization Quality of Life-BREF (WHOQoL-BREF) - Physical Health Domain(Baseline (pre-surgery) and 12 weeks post-arthroscopy)
- Change in WHOQoL-BREF - Social Relationships Domain(Baseline (pre-surgery) and 12 weeks post-arthroscopy)
- Change in WHOQoL-BREF - Environment Domain(Baseline (pre-surgery) and 12 weeks post-arthroscopy)
- Incidence of Adverse Events(Throughout the 12-week study period)
- Incidence of Serious Adverse Events(Throughout 12-week study period)
研究者
Maria Zabrzyńska
MD PhD
Collegium Medicum w Bydgoszczy