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Prospective Randomized Trial of Hyaluronan Injection Efficacy for Long-term Prognosis in Knee Osteoarthritis

Prospective Randomized Trial of Hyaluronan Injection Efficacy for Long-term Prognosis in Knee Osteoarthritis - HELP Study for Knee OA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017962
Enrollment
360
Registered
2015-06-19
Start date
2015-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

knee osteoarthritis

Interventions

Intervention/ 5-time weekly hyaluronan injection combined with monthly repetitive injections Control / Only 5-time weekly hyaluronan injection

Sponsors

Tokyo Medical and Dental University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who show Kellgren-Lawrence grade 1-3 knee osteoarthritis within 3 months 2. Pateints who did not receive hyaluronan injection therapy within recent 3 months 3. Patients who suffer from knee pain 4. Patients who give a written consent to the study

Exclusion criteria

Exclusion criteria: 1. Patients who have neurological and/or vascular complications which may affect the evaluation 2. Patients who have difficulty for evaluation because of their physical and/or mental condition 3. Patients who take not allowed medication for treatment of pain 4. Patients who have ill controlled DM, etc. 5. Patients who have possibility of taking other surgical treatments within a year 6. Patients who live distant from the hospital with difficulty of visiting frequently

Design outcomes

Primary

MeasureTime frame
patient-based subjective assessment

Secondary

MeasureTime frame
Radiographic assessment, MRI evaluation and physical evaluation

Countries

Japan

Contacts

Public ContactKunikazu Tsuji

Tokyo Medial and Dental University Department of Cartilage Regeneration, Graduate School

tsuji.orj@tmd.ac.jp+8158034080

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026