NCT02189408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at below P25 for phase_4 knee-osteoarthritis

Timeline
Completed

Started Jul 2010

Typical duration for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
Last Updated

July 14, 2014

Status Verified

July 1, 2014

Enrollment Period

2.4 years

First QC Date

June 11, 2014

Last Update Submit

July 11, 2014

Conditions

Knee OsteoarthritisCartilage DamageMeniscal Tear

Keywords

Platelet rich plasmaAutologous conditioned plasmaOuterbridge

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • pain ( VAS )

    6 weeks, 12 months

  • knee function (Lysholm-score )

    6 weeks, 6 months, 12 months

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

    6 weeks, 6 months and 12 months

Study Arms (2)

PRP

EXPERIMENTAL

one intraoperative application of PRP in the interventional group

Biological: Platelet rich plasma

Control

NO INTERVENTION

No application of any substance during knee arthroscopy

Interventions

Platelet rich plasmaBIOLOGICAL
Also known as: ACP ( Arthrex )
PRP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • degenerative knee pain
  • age: \> 18 years
  • informed consent
  • none to moderate comorbidity
  • arthroscopy under general anaesthesia indicated

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics at the St. Josef- Hospital

Bochum, 44791, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25957981DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Christoph von Schulze Pellengahr, MD

    Department of Orthopaedics, University Clinic of the Ruhr- University Bochum

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PostDoc Department of Orthopaedics

Study Record Dates

First Submitted

June 11, 2014

First Posted

July 14, 2014

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 14, 2014

Record last verified: 2014-07

Locations

DE(1)