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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Rupture; Subacromial Impingement
• Intervention / Treatment: Biological: Platelet Rich Plasma

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Nieuwegein, Netherlands, 3430 EM
    • St. Antoniusziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VAS pain	Change in painscore measured on a VAS scale	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional recovery	Several questionnaires (RAND-36, SST, and Constant score) and functional tests are measured (Range of motion)	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)	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)	2 years

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 11, 2012
• First Posted (Estimate): January 16, 2012

Study Record Updates

• Last Update Posted (Estimate): May 1, 2014
• Last Update Submitted That Met QC Criteria: April 30, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Rupture; Shoulder Impingement Syndrome
• Other Study ID Numbers: R-08.05A/PDGF; NL19106.100.07 (Other Identifier: CCMO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No