Autologous Protein Solution in the management of knee osteoarthritis

Phase 4

Recruiting

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12621000220864
• Lead Sponsor: orthland DHB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-03
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Unilateral knee osteoarthritis
Kellgren-Lawrence grade 2-3
Failed at least one non-operative management
BMI <40

Exclusion Criteria

Active infection
Osteoarthritis in the contralateral knee
Diagnosis other than osteoarthritis (e.g. inflammatory arthritis, gout, paget's disease, etc) in the affected knee
Other cause for pain as judged by the investigator (e.g. hip, spine pathology, acute injury)
Presence of surgical implants in the affected knee
Arthroscopic surgery on the affected knee within 6 months
Steroid injection in the affected knee within 3 months
Oral steroids within 2 weeks, or other systemic immunosuppressants within 6 weeks
Planned surgery on the affected knee
Local anaesthetic allergy
Current treatment for leakaemia or other malignancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WOMAC score<br><br>The first primary outcome will be osteoarthritis severity as rated by the overall WOMAC score between the two groups at each time period[1,3,6 and 12 months ];Koos pain subscore<br><br>The second primary outcome will be osteoarthritis pain severity as rated by the KOOS pain subscore score between the two groups at each time period[1,3,6 and 12 months];KOOS ADL function subscore<br><br>The third primary outcome will be osteoarthritis functional impariment as rated by the KOOS ADL function score between the two groups at each time period[1, 3, 6, and 12 months]