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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189408
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Christian Duif MD, Ruhr University of Bochum

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Cartilage Damage Meniscal Tear Biological: Platelet rich plasma Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PRP
one intraoperative application of PRP in the interventional group
 Biological: Platelet rich plasma
Other Name: ACP ( Arthrex )
No Intervention: Control
No application of any substance during knee arthroscopy


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. knee function (Lysholm-score ) [ Time Frame: 6 weeks, 6 months, 12 months ]
    to determine PRP-related gain of function according to time after application

  3. 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 )


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189408


Locations
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Germany
Department of Orthopaedics at the St. Josef- Hospital
Bochum, Germany, 44791
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
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Study Director: Christoph von Schulze Pellengahr, MD Department of Orthopaedics, University Clinic of the Ruhr- University Bochum
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christian Duif MD, PostDoc Department of Orthopaedics, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT02189408    
Other Study ID Numbers: PRP-Bochum
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Keywords provided by Christian Duif MD, Ruhr University of Bochum:
Platelet rich plasma
Autologous conditioned plasma
Outerbridge
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases