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Completed

NCT Number: NCT02189408

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Cartilage Damage Joint Diseases Meniscal Tear Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Orthopaedics at the St. Josef- Hospital

Bochum, 44791, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet rich plasma

Biological

Other names: ACP ( Arthrex )

Primary outcomes

  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 outcomes

  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 )

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study 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

Acronym: PRP-Bochum

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 14, 2014
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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