NCT07476508

"Intra-articular Hyaluronic Acid Injection for Accelerating Functional Recovery After Knee Arthroscopy"

"Intra-articular Hyaluronic Acid Injection Significantly Accelerates Functional Recovery After Knee Arthroscopy: A Prospective Randomized Controlled Trial"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Collegium Medicum w Bydgoszczy · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Meniscus Lesion
• Knee Injuries
• Medial Meniscus Tear

Interventions

Type	Name	Description
BEHAVIORAL	Standard 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_SUPPLEMENT	Oral 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
DEVICE	ntra-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

Timeline

• Start date: 2019-10-10
• Primary completion: 2021-12-31
• Completion: 2022-03-31
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

2 sites across 1 country: Poland