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

  • Germany
      • Bochum, Germany, 44791
        • Department of Orthopaedics at the St. Josef- Hospital

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
Biological: Platelet rich plasma
Other Names:
  • ACP ( Arthrex )
No Intervention: Control
No application of any substance during knee arthroscopy

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.
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
6 weeks, 12 months
knee function (Lysholm-score )
Time Frame: 6 weeks, 6 months, 12 months
to determine PRP-related gain of function according to time after application
6 weeks, 6 months, 12 months
quality of life ( physical und mental summaries of SF-36 German version )
Time Frame: 6 weeks, 6 months and 12 months
to identify a possible effect of PRP application on life quality ( physical and mental summaries )
6 weeks, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

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.

General Publications

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

Keywords

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.

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