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The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery (PRP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. N. Wolterbeek, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01510639
First received: January 9, 2012
Last updated: April 30, 2014
Last verified: April 2014

January 9, 2012
April 30, 2014
July 2010
July 2013   (final data collection date for primary outcome measure)
Change in VAS pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Change in painscore measured on a VAS scale
Same as current
Complete list of historical versions of study NCT01510639 on ClinicalTrials.gov Archive Site
  • Functional recovery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Several questionnaires (RAND-36, SST, and Constant score) and functional tests are measured (Range of motion)
  • The amount of patients that had adequate wound healing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    At different follow-up moments would healing is evaluated (6 weeks - 12 weeks - 1 year - 2 years)
  • The amount of patient who were able to resume their work [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    At different follow-up moments it is evaluated if patients was able to resume work (6 weeks - 12 weeks - 1 year - 2 years)
Same as current
Not Provided
Not Provided
 
The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Rotator Cuff Rupture
  • Subacromial Impingement
Biological: Platelet Rich Plasma
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.
  • Experimental: Cuff repair PRP
    Cuff repair Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the cuff repair group
    Intervention: Biological: Platelet Rich Plasma
  • No Intervention: Cuff repair Control
    No intervention
  • Experimental: NEER PRP
    Neer Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the NEER surgery group
    Intervention: Biological: Platelet Rich Plasma
  • No Intervention: NEER Control
    No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
April 2014
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01510639
R-08.05A/PDGF, NL19106.100.07
No
Dr. N. Wolterbeek, St. Antonius Hospital
St. Antonius Hospital
Not Provided
Principal Investigator: Petra E Flikweert, drs St Antoniusziekenhuis
Principal Investigator: Gie Auw yang, Dr St. Antoniusziekenhuis
Principal Investigator: Jacco Zijl, drs St. Antoniusziekenhuis
St. Antonius Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP