Clinical Study of Pain Reduction by Peri-arthroscopic PRP Application in Knee Degeneration

Phase 4

Completed

• Conditions: Knee Osteoarthritis; Cartilage Damage; Meniscal Tear
• Interventions: Biological: Platelet rich plasma

• Registration Number: NCT02189408
• Lead Sponsor: Ruhr University of Bochum

Brief Summary

The purpose of this study is to investigate reduction of pain, gain of function and improvement of life quality by intraoperative applied platelet- rich- plasma ( PRP ) during knee arthroscopy for degeneration and osteoarthritis OA by conducting a randomized- controlled, double-blinded trial ( RCT ) including 58 patients with a follow up of 12 months and pain, assessed by Visual- Analogue Scale (VAS) after 6 months as primary endpoint.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2014-06-11
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-11
• Last Update Submitted: 2014-07-11
• Study First Posted: 2014-07-14
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP	Platelet rich plasma	one intraoperative application of PRP in the interventional group

Primary Outcome Measures

Name	Time	Method
pain ( VAS )	6 months	measurement of pain using a 100 mm VAS as platelet- rich-plasma demonstrated temporarily analgetic effects up to 6-9 months after application.

Secondary Outcome Measures

Name	Time	Method
quality of life ( physical und mental summaries of SF-36 German version )	6 weeks, 6 months and 12 months	to identify a possible effect of PRP application on life quality ( physical and mental summaries )
knee function (Lysholm-score )	6 weeks, 6 months, 12 months	to determine PRP-related gain of function according to time after application
pain ( VAS )	6 weeks, 12 months	To investigate the pain development over the follow up period at the beginning and the end of our trial

Trial Locations

Locations (1)

Department of Orthopaedics at the St. Josef- Hospital; 🇩🇪 Bochum, Germany