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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Knee Osteoarthritis, Cartilage Damage, Meniscal Tear

Intervention / Treatment
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* Biological: Platelet rich plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP<br>one intraoperative application of PRP in the interventional group | Biological: Platelet rich plasma<br> <br> * Other names: ACP ( Arthrex );|
| No Intervention: Control<br>No application of any substance during knee arthroscopy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain ( VAS ) | 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 ) | 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 ) | to identify a possible effect of PRP application on life quality ( physical and mental summaries ) | 6 weeks, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet rich plasma, Autologous conditioned plasma, Outerbridge