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

Subacromial Impingement Clinical Trial

— PRP  

Official title:

Results of Subacromial Surgery; The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510639
• Other study ID #: R-08.05A/PDGF
• Secondary ID: NL19106.100.07
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2012
• Last updated: April 30, 2014
• Start date: July 2010
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Rupture
• Shoulder Impingement Syndrome
• Subacromial Impingement

Intervention

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.

Locations

Country	Name	City	State
Netherlands	st. Antoniusziekenhuis	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VAS pain	Change in painscore measured on a VAS scale	2 years	No
Secondary	Functional recovery	Several questionnaires (RAND-36, SST, and Constant score) and functional tests are measured (Range of motion)	2 years	No
Secondary	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	No
Secondary	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	No