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Completed

NCT Number: NCT07241442

Cross-linked Hyaluronic Acid in Knee Osteoarthritis

Knee Osteoarthritis (Knee OA) leads to pain and loss of function, especially in recreational athletes. While hyaluronic acid (HA) injections are a common part of conservative treatment, comparative data on the efficacy of straight-chain (ST-HA) versus cross-linked (CL-HA) formulations remain limited. Therefore, the aim of this study was to compare the 6-month efficacy of a single dose of CL-HA versus two doses of ST-HA regarding pain, stiffness, and joint function in recreational athletes aged 50-70 with Kellgren-Lawrence grade 2-3 Knee OA refractory to pharmacological treatment.

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Key information

Conditions

Knee Osteoarthritis (Knee OA) Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

About this study

This retrospective observational study included 88 recreational athletes (CL-HA: n=44, ST-HA: n=44). All participants received either a single dose of CL-HA or two doses of ST-HA administered 4 weeks apart. Patients were comparatively evaluated pre-treatment and at 1, 3, and 6 months post-treatment using the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) and VAS scores.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria: Recreational athletes aged 50-70 years; participants must not have received any injections or undergone physical therapy or rehabilitation in the last 3 months; and symptomatic cases of Kellgren-Lawrence stage 2-3 knee osteoarthritis and failure of pharmacological treatment.

Exclusion criteria

Inflammatory disease, active rheumatic disease, malignancy, bleeding diathesis, peripheral neuropathy, BMI >30, grade 4 gonarthrosis, regular NSAID use, previous knee surgery, local infection at the procedure site, corticosteroid injection at the procedure site within the last 3 months, systemic corticosteroid use within the last 2 weeks, immunosuppressant use or immunodeficiency within the last 6 weeks, and any local or systemic osteoarthritis-related treatments (therapeutic exercises, physical therapy, other injections, NSAIDs, etc.) within the last 6 months.

Treatment and study plan

Straight-bonded hyaluronic acid

Drug

Straight-bonded HA injection was applied in 2 doses, 4 weeks apart.

cross-linked hyaluronic acid

Drug

Cross-linked HA was applied as a single dose to the knee via the anterolateral approach.

Primary outcomes

  1. Patients were comparatively evaluated pre-treatment and at 1, 3, and 6 months post-treatment using the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score.

    Time frame: Patients were comparatively evaluated pre-treatment and at 1, 3, and 6 months post-treatment

    Minimal value is 0, while maximum value is 96.

Secondary outcomes

  1. Patients were comparatively evaluated pre-treatment and at 1, 3, and 6 months post-treatment using the VAS score.

    Time frame: Patients were comparatively evaluated pre-treatment and at 1, 3, and 6 months post-treatment

    Minimal value is 0, while maximum value is 10.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Clinical Superiority of Cross-linked Hyaluronic Acid in Knee Osteoarthritis: Sustained Efficacy on Pain and Function

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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