'Intra-articular Hyaluronic Acid Injection for Accelerating Functional Recovery After Knee Arthroscopy'
"Intra-articular Hyaluronic Acid Injection for Accelerating Functional Recovery After Knee Arthroscopy"
NCT ID: NCT07476508 Phase: NA Status: COMPLETED Enrollment: 290 Completion: 2022-03-31
Conditions
Meniscus Lesion, Knee Injuries, Medial Meniscus Tear
Interventions
Standard Postoperative Rehabilitation Protocol, Oral Chondroitin Sulfate (Flextrum), ntra-articular Hyaluronic Acid Injection (Biolevox)
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.
Primary Outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total Score