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"Intra-articular Hyaluronic Acid Injection Significantly Accelerates Functional Recovery After Knee Arthroscopy: A Prospective Randomized Controlled Trial"
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Department of Orthopedics Collegium Medicum, Nicolaus Copernicus University
Bydgoszcz, Poland
Department of Orthopaedics and Traumatology, Regional Hospita
Grudziądz, Poland
Start Date
October 10, 2019
Primary Completion Date
December 31, 2021
Completion Date
March 31, 2022
Last Updated
March 17, 2026
290
ACTUAL participants
Standard Postoperative Rehabilitation Protocol
BEHAVIORAL
Oral Chondroitin Sulfate (Flextrum)
DIETARY_SUPPLEMENT
ntra-articular Hyaluronic Acid Injection (Biolevox)
DEVICE
Lead Sponsor
Collegium Medicum w Bydgoszczy
NCT06541756
NCT07201597
Data Source & Attribution
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