Efficacy of intra-articular polynucleotides in the treatment of knee osteoarthritis

Efficacy of intra-articular polynucleotides in the treatment of knee osteoarthritis: a controlled, randomised, double-blind clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77293496

Enrollment

Registered

2009-04-20

Start date

2006-12-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Knee osteoarthritis Musculoskeletal Diseases Polyarthrosis

Interventions

The product under study is a class III medical device, a gel, consisting of highly purified - natural origin long chain polynucleotides (20 mg/ml concentration). It is marked in a pre-filled glass syr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years, either sex 2. Affected by knee osteoarthritis (diagnosis based on the American College of Rheumatology [ACR] classification) 3. Developed persistent pain for at least two months

Exclusion criteria

Exclusion criteria: 1. Alcohol or drug abuse 2. Pregnancy or breastfeeding 3. Hypersensibility to study products 4. Hyaluronic acid or steroid infiltration therapy ongoing or suspended for less than 3 months 5. Systemic treatment with anticoagulants and steroids ongoing or suspended for less than 1 month 6. Previous bone fractures or severe traumas of the interested knee 7. Presence of rheumatoid arthritis and of relevant haematological pathologies

Design outcomes

Primary

Measure	Time frame
Change in the pain level at rest, at weight-bearing, and during physical activity, at all timepoints from baseline (T0) to T16. Timepoints: T0: Inclusion visit T1: After one week T2: After two weeks T3: After three weeks T4: After four weeks (end of treatment period) T8: First follow-up visit, after eight weeks T16: End of the trial, after 16 weeks	—

Secondary

Measure	Time frame
1. Evaluation of Knee Osteoarthritis Outcome Score (KOOS) results, measured at T0, T4, T8 and T16 2. Non-steroidal anti-inflammatory drug (NSAID) consumption, at all timepoints from baseline (T0) to T16 3. Crackling during movement and articular mobility limitation (LMA), at all timepoints from baseline (T0) to T16 4. Safety profile of the devices, assessed by recording adverse events at each visit Timepoints: T0: Inclusion visit T1: After one week T2: After two weeks T3: After three weeks T4: After four weeks (end of treatment period) T8: First follow-up visit, after eight weeks T16: End of the trial, after 16 weeks	—

Measure

Time frame

1. Evaluation of Knee Osteoarthritis Outcome Score (KOOS) results, measured at T0, T4, T8 and T16 2. Non-steroidal anti-inflammatory drug (NSAID) consumption, at all timepoints from baseline (T0) to T16 3. Crackling during movement and articular mobility limitation (LMA), at all timepoints from baseline (T0) to T16 4. Safety profile of the devices, assessed by recording adverse events at each visit Timepoints: T0: Inclusion visit T1: After one week T2: After two weeks T3: After three weeks T4: After four weeks (end of treatment period) T8: First follow-up visit, after eight weeks T16: End of the trial, after 16 weeks

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026