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
  Purpose

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.


Condition Intervention Phase
Rotator Cuff Rupture
Subacromial Impingement
Biological: Platelet Rich Plasma
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Results of Subacromial Surgery; The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery

Resource links provided by NLM:


Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • Change in VAS pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change in painscore measured on a VAS scale


Secondary Outcome Measures:
  • 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)


Enrollment: 73
Study Start Date: July 2010
Study Completion Date: April 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cuff repair PRP
Cuff repair Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the cuff repair group
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.
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
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.
No Intervention: NEER Control
No intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510639

Locations
Netherlands
st. Antoniusziekenhuis
Nieuwegein, Netherlands, 3430 EM
Sponsors and Collaborators
St. Antonius Hospital
Investigators
Principal Investigator: Petra E Flikweert, drs St Antoniusziekenhuis
Principal Investigator: Gie Auw yang, Dr St. Antoniusziekenhuis
Principal Investigator: Jacco Zijl, drs St. Antoniusziekenhuis
  More Information

No publications provided

Responsible Party: Dr. N. Wolterbeek, Study Coordinator, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01510639     History of Changes
Other Study ID Numbers: R-08.05A/PDGF, NL19106.100.07
Study First Received: January 9, 2012
Last Updated: April 30, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Rupture
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 09, 2014