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

R

Ruhr University of Bochum

Status and phase

Completed
Phase 4

Conditions

Cartilage Damage
Meniscal Tear
Knee Osteoarthritis

Treatments

Biological: Platelet rich plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT02189408
PRP-Bochum

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

58 participants in 2 patient groups

PRP
Experimental group
Description:
one intraoperative application of PRP in the interventional group
Treatment:
Biological: Platelet rich plasma
Control
No Intervention group
Description:
No application of any substance during knee arthroscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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