Clinical Study of Pain Reduction by Peri-arthroscopic PRP Application in Knee Degeneration (PRP-Bochum)
July 11, 2014 updated by: Christian Duif MD, Ruhr University of Bochum
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bochum, Germany, 44791
- Department of Orthopaedics at the St. Josef- Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRP
one intraoperative application of PRP in the interventional group
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Other Names:
|
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No Intervention: Control
No application of any substance during knee arthroscopy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain ( VAS )
Time Frame: 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.
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain ( VAS )
Time Frame: 6 weeks, 12 months
|
To investigate the pain development over the follow up period at the beginning and the end of our trial
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6 weeks, 12 months
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knee function (Lysholm-score )
Time Frame: 6 weeks, 6 months, 12 months
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to determine PRP-related gain of function according to time after application
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6 weeks, 6 months, 12 months
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quality of life ( physical und mental summaries of SF-36 German version )
Time Frame: 6 weeks, 6 months and 12 months
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to identify a possible effect of PRP application on life quality ( physical and mental summaries )
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6 weeks, 6 months and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Christoph von Schulze Pellengahr, MD, Department of Orthopaedics, University Clinic of the Ruhr- University Bochum
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
June 11, 2014
First Submitted That Met QC Criteria
July 11, 2014
First Posted (Estimate)
July 14, 2014
Study Record Updates
Last Update Posted (Estimate)
July 14, 2014
Last Update Submitted That Met QC Criteria
July 11, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRP-Bochum
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.