The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery
PRP
Results of Subacromial Surgery; The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery
2 other identifiers
interventional
73
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 9, 2012
CompletedFirst Posted
Study publicly available on registry
January 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 1, 2014
April 1, 2014
3 years
January 9, 2012
April 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in VAS pain
Change in painscore measured on a VAS scale
2 years
Secondary Outcomes (3)
Functional recovery
2 years
The amount of patients that had adequate wound healing
2 years
The amount of patient who were able to resume their work
2 years
Study Arms (4)
Cuff repair PRP
EXPERIMENTALCuff repair Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the cuff repair group
Cuff repair Control
NO INTERVENTIONNo intervention
NEER PRP
EXPERIMENTALNeer Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the NEER surgery group
NEER Control
NO INTERVENTIONNo intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Coagulopathy
- Thrombocytopenia
- Use of corticosteroids
- Diabetics Mellitus
- Omarthritis
- AC-arthrosis
- Cuff arthropathy
- Neurological deficit at the ipsi-lateral extremity
- (Wish for) Pregnancy
- VAS \<2 or VAS \>9
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
st. Antoniusziekenhuis
Nieuwegein, 3430 EM, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petra E Flikweert, drs
St Antoniusziekenhuis
- PRINCIPAL INVESTIGATOR
Gie Auw yang, Dr
St. Antoniusziekenhuis
- PRINCIPAL INVESTIGATOR
Jacco Zijl, drs
St. Antoniusziekenhuis
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Coordinator
Study Record Dates
First Submitted
January 9, 2012
First Posted
January 16, 2012
Study Start
July 1, 2010
Primary Completion
July 1, 2013
Study Completion
April 1, 2014
Last Updated
May 1, 2014
Record last verified: 2014-04