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

Primary Purpose

Knee Osteoarthritis, Cartilage Damage, Meniscal Tear

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Platelet rich plasma

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Platelet rich plasma, Autologous conditioned plasma, Outerbridge

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Orthopaedics at the St. Josef- Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PRP

Control

Arm Description

one intraoperative application of PRP in the interventional group

No application of any substance during knee arthroscopy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

pain ( VAS )

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

knee function (Lysholm-score )

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

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 )

Full Information

NCT ID

NCT02189408

First Posted

June 11, 2014

Last Updated

July 11, 2014

Sponsor

Ruhr University of Bochum

1. Study Identification

Unique Protocol Identification Number

NCT02189408

Brief Title

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

Acronym

PRP-Bochum

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruhr University of Bochum

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis, Cartilage Damage, Meniscal Tear

Keywords

Platelet rich plasma, Autologous conditioned plasma, Outerbridge

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRP

Arm Type

Experimental

Arm Description

one intraoperative application of PRP in the interventional group

Arm Title

Control

Arm Type

No Intervention

Arm Description

No application of any substance during knee arthroscopy

Intervention Type

Biological

Intervention Name(s)

Platelet rich plasma

Other Intervention Name(s)

ACP ( Arthrex )

Primary Outcome Measure Information:

Title

pain ( VAS )

Description

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 Outcome Measure Information:

Title

pain ( VAS )

Description

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

Title

knee function (Lysholm-score )

Description

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

Time Frame

6 weeks, 6 months, 12 months

Title

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

Description

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

Time Frame

6 weeks, 6 months and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph von Schulze Pellengahr, MD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Department of Orthopaedics at the St. Josef- Hospital

City

Bochum

ZIP/Postal Code

44791

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25957981

Citation

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.

Results Reference

derived

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

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