Clinical trial on the intra-articular efficacy of MD-Knee (collagen medical device-knee) versus sodium hyaluronate in patients with knee osteoarthritis

A double blind randomized active-controlled clinical trial on the intra-articular use of MD-Knee versus sodium hyaluronate in patients with knee osteoarthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93862496

Enrollment

Registered

2016-01-18

Start date

2013-05-02

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Osteoarthritis (OA) Musculoskeletal Diseases Osteoarthritis (OA)

Interventions

Participants are randomly allocated to one of two groups. Group A: Participants are treated using MD-Knee (Guna S.p.a., Milan, Italy), administered via the intra-articular injection of two 2.0 ml amp

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Ambulatory adult patients affected by knee OA 2. Diagnosis of OA according to the ARA (American Rheumatism Association) criteria 3. Ages 40 years or over 4. Score greater than 7.0 on the Lequesne Knee Index at baseline 5. Persistence of pain in the knee for at least the last three months 6. Radiological degree II-III according to the Kellgren-Lawrence scale 7. Patients able to comply with the study procedures

Exclusion criteria

Exclusion criteria: 1. Presence of comorbidities (i.e. rheumatoid arthritis, spondyloarthritis, connective tissue disease, polymyalgia rheumatica, gout, Paget's disease, septic arthritis, fractures, osteonecrosis, and fibromyalgia) 2. Patients with skin or subcutaneous tissue infection in the area of the joint to be treated 3. Patients who had used oral, parenteral or intra-articular corticosteroids in the preceding three months 4. Patients taking topical analgesics that may interfere with the evaluation of the study 5. Patients on anticoagulant therapy or suffering from thrombocytopenia and/or coagulopathy 6. Patient with allergy to products of porcine origins

Design outcomes

Primary

Measure	Time frame
Clinical improvement of condition is measured using the lequesne knee index (LKI) score at baseline and 3 months.	—

Secondary

Measure	Time frame
1. Clinical improvement of condition is measured using the lequesne knee index (LKI) score at baseline and 6 months 2. Pain is measured using the visual analogue scale (VAS) at baseline, 3 and 6 months 3. Health status is measured using the Short Form (36) Health Survey (SF36) at baseline, 3 and 6 months 4. Pain Killer consumption is measured using a patient diary completed between baseline to 6 months 5. Rate of adverse events (AE) are determined through observation by the investigators and patient reporting using the electronic- Case Report Form (e-CRF) between baseline to 6 months	—

Measure

Time frame

1. Clinical improvement of condition is measured using the lequesne knee index (LKI) score at baseline and 6 months 2. Pain is measured using the visual analogue scale (VAS) at baseline, 3 and 6 months 3. Health status is measured using the Short Form (36) Health Survey (SF36) at baseline, 3 and 6 months 4. Pain Killer consumption is measured using a patient diary completed between baseline to 6 months 5. Rate of adverse events (AE) are determined through observation by the investigators and patient reporting using the electronic- Case Report Form (e-CRF) between baseline to 6 months

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026