Knee Injuries, Medial Meniscus Tear, Meniscus Lesion
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStandard Postoperative Rehabilitation Protocol
Evidence-based 12-week progressive rehabilitation program consisting of four phases progressing from joint protection through functional strengthening, including partial/full weight-bearing progression, ROM exercises, quadriceps/hamstring strengthening, balance training, and functional exercises. Arm Group Labels: Control - Standard Rehabilitation; Oral Chondroitin Sulfate Supplementation; Intra-articular Hyaluronic Acid Viscosupplementation
DIETARY_SUPPLEMENTOral Chondroitin Sulfate (Flextrum)
Flextrum tablets containing 1200mg chondroitin sulfate and 40mg Vitamin C taken orally once daily for 12 weeks starting immediately post-arthroscopy. Arm Group Labels: Oral Chondroitin Sulfate Supplementation
DEVICEntra-articular Hyaluronic Acid Injection (Biolevox)
Biolevox™ HA 2.2% (concentration 22mg/mL, volume 2mL per injection, molecular weight 1400-2400 kDa, bacterial fermentation origin) administered via ultrasound-guided intra-articular injection using lateral mid-patellar approach with knee in full extension. Two injections total: first at 2 weeks post-arthroscopy and second at 6 weeks post-arthroscopy. Manufacturer: Biovico Sp. z o.o., Gdynia, Poland Arm Group Labels: Intra-articular Hyaluronic Acid Viscosupplementation
Sponsors
Collegium Medicum w Bydgoszczy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in KOOS Pain Subscale Score | Baseline (pre-surgery) and 12 weeks post-arthroscopy | The KOOS Pain subscale consists of 9 items assessing pain frequency and severity during various activities. Scores range from 0 (extreme pain) to 100 (no pain). Higher scores indicate less pain and better outcomes. |
| Change in World Health Organization Quality of Life-BREF (WHOQoL-BREF) - Physical Health Domain | Baseline (pre-surgery) and 12 weeks post-arthroscopy | The WHOQoL-BREF is a 26-item questionnaire evaluating health-related quality of life. The Physical Health domain assesses activities of daily living, dependence on medications or medical aids, energy and fatigue, mobility, pain and discomfort, sleep and rest, and work capacity. Domain scores are transformed to a 0-100 scale, where higher scores indicate better quality of life. |
| Change in WHOQoL-BREF - Social Relationships Domain | Baseline (pre-surgery) and 12 weeks post-arthroscopy | The Social Relationships domain of WHOQoL-BREF assesses personal relationships, social support, and sexual activity. Scores transformed to a 0-100 scale, where higher scores indicate better social relationships. |
| Change in WHOQoL-BREF - Environment Domain | Baseline (pre-surgery) and 12 weeks post-arthroscopy | The Environment domain of WHOQoL-BREF assesses financial resources, freedom/physical safety/security, health and social care accessibility and quality, home environment, opportunities for acquiring information and skills, participation in and opportunities for recreation/leisure activities, physical environment, and transport. Scores transformed to 0-100 scale where higher scores indicate better environmental quality of life. |
| Incidence of Adverse Events | Throughout the 12-week study period | Number of participants experiencing any adverse events, including but not limited to: infection, joint effusion, allergic reactions, injection-site complications, gastrointestinal symptoms, or any other treatment-related adverse effects. Safety will be assessed through participant self-report and clinical examination. |
| Incidence of Serious Adverse Events | Throughout 12-week study period | Number of participants experiencing serious adverse events (SAEs) defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORMaria Zabrzyńska, MD PhD
Department of Family Medicine
Outcome results
None listed