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

NCT07476508 | Completed

• 1 other identifier: 1.0 10.10.2019
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 2

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.

Conditions

Meniscus Lesion; Knee Injuries; Medial Meniscus Tear

Outcome Measures

Primary Outcomes (1)

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total Score

  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.

  Baseline (pre-surgery) and 12 weeks post-arthroscopy

Secondary Outcomes (6)

• 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

Study Arms (3)

Control - Standard Rehabilitation

ACTIVE COMPARATOR

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.

Behavioral: Standard Postoperative Rehabilitation Protocol

Oral Chondroitin Sulfate Supplementation

EXPERIMENTAL

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.

Behavioral: Standard Postoperative Rehabilitation Protocol; Dietary Supplement: Oral Chondroitin Sulfate (Flextrum)

Intra-articular Hyaluronic Acid Viscosupplementation

EXPERIMENTAL

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.

Behavioral: Standard Postoperative Rehabilitation Protocol; Device: ntra-articular Hyaluronic Acid Injection (Biolevox)

Interventions

Standard Postoperative Rehabilitation Protocol BEHAVIORAL

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

Control - Standard Rehabilitation; Intra-articular Hyaluronic Acid Viscosupplementation; Oral Chondroitin Sulfate Supplementation

Oral Chondroitin Sulfate (Flextrum) DIETARY_SUPPLEMENT

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

Oral Chondroitin Sulfate Supplementation

ntra-articular Hyaluronic Acid Injection (Biolevox) DEVICE

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

Intra-articular Hyaluronic Acid Viscosupplementation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (2)

Department of Orthopedics Collegium Medicum, Nicolaus Copernicus University

Bydgoszcz, Poland

Location

Department of Orthopaedics and Traumatology, Regional Hospita

Grudziądz, Poland

Location

MeSH Terms

Conditions

Knee Injuries

Interventions

Chondroitin Sulfates

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chondroitin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Maria Zabrzyńska, MD PhD

  Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: October 10, 2019
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)