Knee Osteoarthritis (Knee OA)NCT07241442
Cross-linked Hyaluronic Acid in Knee Osteoarthritis
An observational study of Knee Osteoarthritis (Knee OA), run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Straight-bonded hyaluronic acid and cross-linked hyaluronic acid
- Type of treatment
- Injection or infusion
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2021to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This retrospective observational study was conducted in a multicenter manner and included recreational athletes aged between 50 and 70 years who applied to Medipol Esenler Hospital and Republic of Turkey Ministry of Health Erenköy Physical Therapy and Rehabilitation Hospital due to knee pain and were diagnosed with gonarthrosis between January 2021 and December 2024.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Superiority of Cross-linked Hyaluronic Acid in Knee Osteoarthritis: Sustained Efficacy on Pain and Function
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.
Read the detailed description
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.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Straight-bonded hyaluronic acid, cross-linked hyaluronic acid
- Keywords
- Knee Osteoarthritis, Cross-linked Hyaluronic Acid, Recreational Athletes, Intra-articular Injection, WOMAC
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straight-bonded hyaluronic acidDrug
Straight-bonded HA injection was applied in 2 doses, 4 weeks apart.
cross-linked hyaluronic acidDrug
Cross-linked HA was applied as a single dose to the knee via the anterolateral approach.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Minimal value is 0, while maximum value is 96.
Measured: Patients were comparatively evaluated pre-treatment and at 1, 3, and 6 months post-treatment
Secondary outcomes (1)
Patients were comparatively evaluated pre-treatment and at 1, 3, and 6 months post-treatment using the VAS score.
Minimal value is 0, while maximum value is 10.
Measured: Patients were comparatively evaluated pre-treatment and at 1, 3, and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start2 Jan 2021
- Primary completion31 Dec 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda Ersahan, DDS, PhD, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241442
- Sponsor's protocol ID
- E-10840098-202.3.02-5817
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication in a journal, I will share all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Superiority of Cross-linked Hyaluronic Acid in Knee Osteoarthritis: Sustained Efficacy on Pain and Function
- ClinicalTrials.gov ID
- NCT07241442
- Acronym / sponsor ID
- E-10840098-202.3.02-5817
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- Knee Osteoarthritis, Cross-linked Hyaluronic Acid, Recreational Athletes, Intra-articular Injection, WOMAC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective observational study was conducted in a multicenter manner and included recreational athletes aged between 50 and 70 years who applied to Medipol Esenler Hospital and Republic of Turkey Ministry of Health Erenköy Physical Therapy and Rehabilitation Hospital due to knee pain and were diagnosed with gonarthrosis between January 2021 and December 2024.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Straight-bonded hyaluronic acidStraight-bonded HA injection was applied in 2 doses, 4 weeks apart. | Drug | – |
| cross-linked hyaluronic acidCross-linked HA was applied as a single dose to the knee via the anterolateral approach. | Drug | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. After publication in a journal, I will share all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis (Knee OA), run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.