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

Knee Osteoarthritis Clinical Trial

— PRP-Bochum  

Official title:

Effect of Platelet Rich Plasma ( PRP ) Applied During Knee Arthroscopy on Pain, Function and Quality of Life - A RCT With a Follow up of 12 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189408
• Other study ID #: PRP-Bochum
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2014
• Last updated: July 11, 2014
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2014
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

inclusion Criteria:

• degenerative knee pain

• age: > 18 years

• informed consent

• none to moderate comorbidity

• arthroscopy under general anaesthesia indicated

exclusion Criteria:

• trauma of the knee within the last 6 weeks before surgery

• circumscribed cartilage lesion with possibility of repair microfracture or autologous chondrocyte transplantation - procedures

• contraindications against PRP. application

• malignancies

• severe comorbidities

• age <18 years

• physically or mentally not able to provide informed consent

• severe knee instability

• corticosteroid injections within the last 6 weeks before surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cartilage Damage
• Knee Osteoarthritis
• Meniscal Tear
• Osteoarthritis, Knee

Intervention

Biological:
• Platelet rich plasma

Locations

Country	Name	City	State
Germany	Department of Orthopaedics at the St. Josef- Hospital	Bochum

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain ( VAS )	measurement of pain using a 100 mm VAS as platelet- rich-plasma demonstrated temporarily analgetic effects up to 6-9 months after application.	6 months	No
Secondary	pain ( VAS )	To investigate the pain development over the follow up period at the beginning and the end of our trial	6 weeks, 12 months	No
Secondary	knee function (Lysholm-score )	to determine PRP-related gain of function according to time after application	6 weeks, 6 months, 12 months	No
Secondary	quality of life ( physical und mental summaries of SF-36 German version )	to identify a possible effect of PRP application on life quality ( physical and mental summaries )	6 weeks, 6 months and 12 months	No

External Links

•   Website of the Department of Orthopaedics