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

Ruhr University of Bochum58 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Knee Osteoarthritis Cartilage Damage Meniscal Tear

Interventions

Platelet rich plasmaBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Orthopaedics at the St. Josef- Hospital

Bochum, Germany

Outcomes

Primary Outcomes

pain ( VAS )

measurement of pain using a 100 mm VAS as platelet- rich-plasma demonstrated temporarily analgetic effects up to 6-9 months after application.

Time frame: 6 months

Secondary Outcomes

pain ( VAS )

To investigate the pain development over the follow up period at the beginning and the end of our trial

Time frame: 6 weeks, 12 months

knee function (Lysholm-score )

to determine PRP-related gain of function according to time after application

Time frame: 6 weeks, 6 months, 12 months

quality of life ( physical und mental summaries of SF-36 German version )

to identify a possible effect of PRP application on life quality ( physical and mental summaries )

Time frame: 6 weeks, 6 months and 12 months

Data from ClinicalTrials.gov

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