Knee OsteoarthritisPhase 4PRP-BochumNCT02189408
Clinical Study of Pain Reduction by Peri-arthroscopic PRP Application in Knee Degeneration
A Phase 4 study testing Platelet rich plasma in people with Knee Osteoarthritis and Cartilage Damage, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Cartilage Damage, Meniscal Tear
- What is being tested?
- Platelet rich plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- degenerative knee pain
- age: > 18 years
- informed consent
- none to moderate comorbidity
- arthroscopy under general anaesthesia indicated
Who cannot join
- 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
Show all 9Show fewer
- physically or mentally not able to provide informed consent
- severe knee instability
- corticosteroid injections within the last 6 weeks before surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Orthopaedics at the St. Josef- Hospital
Bochum, 44791
About this study
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
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.
- Conditions
- Knee Osteoarthritis, Cartilage Damage, Meniscal Tear
- Being tested
- Platelet rich plasma
- Keywords
- Platelet rich plasma, Autologous conditioned plasma, Outerbridge
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaBiological
Also called ACP ( Arthrex )
| Study group | Role | What they receive |
|---|---|---|
| PRP | Experimental | one intraoperative application of PRP in the interventional group Receives: Biological: Platelet rich plasma |
| Control | No intervention | No application of any substance during knee arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
pain ( VAS )
To investigate the pain development over the follow up period at the beginning and the end of our trial
Measured: 6 weeks, 12 months
knee function (Lysholm-score )
to determine PRP-related gain of function according to time after application
Measured: 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 )
Measured: 6 weeks, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Duif MD, Ruhr University of Bochum
- Investigators
- Christoph von Schulze Pellengahr, MD, Study director, Department of Orthopaedics, University Clinic of the Ruhr- University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189408
- Sponsor's protocol ID
- PRP-Bochum
- Acronym
- PRP-Bochum
- Status last verified
- Jul 2014
- First submitted
- 11 Jun 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25957981
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02189408
- Acronym / sponsor ID
- PRP-Bochum / PRP-Bochum
- Conditions
- Knee Osteoarthritis, Cartilage Damage, Meniscal Tear
- Keywords
- Platelet rich plasma, Autologous conditioned plasma, Outerbridge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Biological: Platelet rich plasmaone intraoperative application of PRP in the interventional group |
| Control | No intervention | –No application of any substance during knee arthroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- degenerative knee pain
- age: > 18 years
- informed consent
- none to moderate comorbidity
- arthroscopy under general anaesthesia indicated
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasmaAlso: ACP ( Arthrex ) | Biological | PRP |
Primary outcome
pain ( VAS )
Time frame: 6 months
measurement of pain using a 100 mm VAS as platelet- rich-plasma demonstrated temporarily analgetic effects up to 6-9 months after application.
3 secondary outcomes
pain ( VAS )
Time frame: 6 weeks, 12 months
knee function (Lysholm-score )
Time frame: 6 weeks, 6 months, 12 months
quality of life ( physical und mental summaries of SF-36 German version )
Time frame: 6 weeks, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Derived from this study: PubMed 25957981Duif 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.
- Website of the Department of OrthopaedicsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph von Schulze Pellengahr, MD study director
Department of Orthopaedics, University Clinic of the Ruhr- University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet rich plasma in people with Knee Osteoarthritis and Cartilage Damage, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain ( VAS ) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02189408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.