Rotator Cuff RupturePhase 3PRPNCT01510639
The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery
A Phase 3 study testing Platelet Rich Plasma in people with Rotator Cuff Rupture and Subacromial Impingement, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
The purpose of this study is to test the hypothesis that the application of PRP leads to faster wound healing, less wound healing disorders, less pain and faster functional recovery after subacromial surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Rupture, Subacromial Impingement
- What is being tested?
- Platelet Rich Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2010to Apr 2014
- Phase
- Phase 3
- 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
- Age >18 years old
- Given informed consent
- Clinical indication for Arthroscopic Sub-acromial decompression, i.e.: Painful arc, pain at abduction, positive Hawkinstest Insufficient clinical improvement after (at least) 6 months of conservative treatment or Clinical indication for a arthroscopic cuff repair of a MRI-proven treatable rotator cuff tear.
Who cannot join
- Coagulopathy
- Thrombocytopenia
- Use of corticosteroids
- Diabetics Mellitus
- Omarthritis
- AC-arthrosis
Show all 10Show fewer
- Cuff arthropathy
- Neurological deficit at the ipsi-lateral extremity
- (Wish for) Pregnancy
- VAS <2 or VAS >9
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results of Subacromial Surgery; The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery
The purpose of this study is to test the hypothesis that the application of PRP leads to faster wound healing, less wound healing disorders, less pain and faster functional recovery after subacromial surgery.
Read the detailed description
Subacromial surgery of the shoulder is performed often. It concerns space creating interventions (open and arthroscopic subacromial decompression) and rotator cuff surgery (open and arthroscopic). In this kind of surgery good wound healing and tissue recovery is of great importance to achieve optimal results. Wound healing disorders, pain and the formation of adhesions may negatively influence the postoperative course and lead to extended rehabilitation. This has an unfavourable influence on the personal well being of the patient and the possibility to return to labour. Especially in cuff surgery the course is strongly influenced by the healing of the attachment of the cuff to the bone. Besides the development of minimal invasive techniques, it's necessary to look for possibilities to decrease the morbidity of these procedures. Recent studies show that growth factors play a major role in wound healing. This concerns particularly TFG-B (transforming growth factor B) and PDGF (platelet derived growth factor) present in thrombocytes. They act as chemotactic agents for polymorphonuclear leucocytes, macrophages, fibroblasts and lymphocytes. Both growth factors stimulate the wound healing and cause improved angiogenesis and fibroplasia. They also play a role in wound retraction and remodelling. In animal-experimental models it is proved that the application of TGF-B and PDGF improves woundhealing and leads to better mechanical properties of the scar tissue. Faster and better wound healing and decreased development of adhesions after subacromial surgery can possibly be influenced favourably by using thrombocyte concentrate. In the treatment with autologous thrombocyte concentrate a thrombocyte rich concentrate is obtained by a centrifuging method (Gravitational Platelet System (GPS), Biomet, Warsaw USA) (platelet rich plasma or PRP), that can be applied in the operating field. The concentrate is harvest from the patients own blood, sampled during the procedure. At random the concentrated is applicated and both groups are compared postoperatively.
- Conditions
- Rotator Cuff Rupture, Subacromial Impingement
- Being tested
- Platelet Rich Plasma
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
The application of autologous thrombocyte concentrate (PRP). This is a concentrate with a high amount of thrombocytes (containing growth factors), obtained by centrifuging the patient's own blood. The concentrate is applied into the subacromial space after closure.
| Study group | Role | What they receive |
|---|---|---|
| Cuff repair PRP | Experimental | Cuff repair Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the cuff repair group Receives: Biological: Platelet Rich Plasma |
| Cuff repair Control | No intervention | No intervention |
| NEER PRP | Experimental | Neer Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the NEER surgery group Receives: Biological: Platelet Rich Plasma |
| NEER Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS pain
Change in painscore measured on a VAS scale
Measured: 2 years
Secondary outcomes (3)
Functional recovery
Several questionnaires (RAND-36, SST, and Constant score) and functional tests are measured (Range of motion)
Measured: 2 years
The amount of patients that had adequate wound healing
At different follow-up moments would healing is evaluated (6 weeks - 12 weeks - 1 year - 2 years)
Measured: 2 years
The amount of patient who were able to resume their work
At different follow-up moments it is evaluated if patients was able to resume work (6 weeks - 12 weeks - 1 year - 2 years)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJul 2010
- Primary completionJul 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff RuptureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. N. Wolterbeek, St. Antonius Hospital
- Investigators
- Petra E Flikweert, drs, Principal investigator, St AntoniusziekenhuisGie Auw yang, Dr, Principal investigator, St. AntoniusziekenhuisJacco Zijl, drs, Principal investigator, St. Antoniusziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510639
- Sponsor's protocol ID
- R-08.05A/PDGF
- Other IDs
- NL19106.100.07
- Acronym
- PRP
- Status last verified
- Apr 2014
- First submitted
- 9 Jan 2012
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Subacromial Surgery; The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery
- ClinicalTrials.gov ID
- NCT01510639
- Acronym / sponsor ID
- PRP / R-08.05A/PDGF
- Conditions
- Rotator Cuff Rupture, Subacromial Impingement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Jan 2012 (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 test the hypothesis that the application of PRP leads to faster wound healing, less wound healing disorders, less pain and faster functional recovery after subacromial surgery.
Detailed description
Subacromial surgery of the shoulder is performed often. It concerns space creating interventions (open and arthroscopic subacromial decompression) and rotator cuff surgery (open and arthroscopic). In this kind of surgery good wound healing and tissue recovery is of great importance to achieve optimal results. Wound healing disorders, pain and the formation of adhesions may negatively influence the postoperative course and lead to extended rehabilitation. This has an unfavourable influence on the personal well being of the patient and the possibility to return to labour. Especially in cuff surgery the course is strongly influenced by the healing of the attachment of the cuff to the bone. Besides the development of minimal invasive techniques, it's necessary to look for possibilities to decrease the morbidity of these procedures. Recent studies show that growth factors play a major role in wound healing. This concerns particularly TFG-B (transforming growth factor B) and PDGF (platelet derived growth factor) present in thrombocytes. They act as chemotactic agents for polymorphonuclear leucocytes, macrophages, fibroblasts and lymphocytes. Both growth factors stimulate the wound healing and cause improved angiogenesis and fibroplasia. They also play a role in wound retraction and remodelling. In animal-experimental models it is proved that the application of TGF-B and PDGF improves woundhealing and leads to better mechanical properties of the scar tissue. Faster and better wound healing and decreased development of adhesions after subacromial surgery can possibly be influenced favourably by using thrombocyte concentrate. In the treatment with autologous thrombocyte concentrate a thrombocyte rich concentrate is obtained by a centrifuging method (Gravitational Platelet System (GPS), Biomet, Warsaw USA) (platelet rich plasma or PRP), that can be applied in the operating field. The concentrate is harvest from the patients own blood, sampled during the procedure. At random the concentrated is applicated and both groups are compared postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cuff repair PRP | Experimental | Biological: Platelet Rich PlasmaCuff repair Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the cuff repair group |
| Cuff repair Control | No intervention | –No intervention |
| NEER PRP | Experimental | Biological: Platelet Rich PlasmaNeer Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the NEER surgery group |
| NEER Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years old
- Given informed consent
- Clinical indication for Arthroscopic Sub-acromial decompression, i.e.: Painful arc, pain at abduction, positive Hawkinstest Insufficient clinical improvement after (at least) 6 months of conservative treatment or Clinical indication for a arthroscopic cuff repair of a MRI-proven treatable rotator cuff tear.
Key exclusion criteria (10 listed)
- Coagulopathy
- Thrombocytopenia
- Use of corticosteroids
- Diabetics Mellitus
- Omarthritis
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 PlasmaThe application of autologous thrombocyte concentrate (PRP). This is a concentrate with a high amount of thrombocytes (containing growth factors), obtained by centrifuging the patient's own blood. The concentrate is applied into the subacromial space after closure. | Biological | Cuff repair PRP, NEER PRP |
Primary outcome
Change in VAS pain
Time frame: 2 years
Change in painscore measured on a VAS scale
3 secondary outcomes
Functional recovery
Time frame: 2 years
The amount of patients that had adequate wound healing
Time frame: 2 years
The amount of patient who were able to resume their work
Time frame: 2 years
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 1 May 2014.
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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.
Petra E Flikweert, drs principal investigator
St Antoniusziekenhuis
Gie Auw yang, Dr principal investigator
St. Antoniusziekenhuis
Jacco Zijl, drs principal investigator
St. Antoniusziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet Rich Plasma in people with Rotator Cuff Rupture and Subacromial Impingement, run by St. Antonius Hospital at 1 site in Netherlands.
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 3 inclusion and 10 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 1 May 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in VAS pain (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2014.