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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

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date July 14, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
  • 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
  • knee function (Lysholm-score ) [ Time Frame: 6 weeks, 6 months, 12 months ]
    to determine PRP-related gain of function according to time after application
  • 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 )
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Pain Reduction by Peri-arthroscopic PRP Application in Knee Degeneration
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Knee Osteoarthritis
  • Cartilage Damage
  • Meniscal Tear
Intervention  ICMJE Biological: Platelet rich plasma
Other Name: ACP ( Arthrex )
Study Arms  ICMJE
  • Experimental: PRP
    one intraoperative application of PRP in the interventional group
    Intervention: Biological: Platelet rich plasma
  • No Intervention: Control
    No application of any substance during knee arthroscopy
Publications * Duif C, Vogel T, Topcuoglu F, Spyrou G, von Schulze Pellengahr C, Lahner M. Does intraoperative application of leukocyte-poor platelet-rich plasma during arthroscopy for knee degeneration affect postoperative pain, function and quality of life? A 12-month randomized controlled double-blind trial. Arch Orthop Trauma Surg. 2015 Jul;135(7):971-7. doi: 10.1007/s00402-015-2227-5. Epub 2015 May 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2014)
58
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189408
Other Study ID Numbers  ICMJE PRP-Bochum
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christian Duif MD, Ruhr University of Bochum
Study Sponsor  ICMJE Ruhr University of Bochum
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christoph von Schulze Pellengahr, MD Department of Orthopaedics, University Clinic of the Ruhr- University Bochum
PRS Account Ruhr University of Bochum
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP