search
Back to results

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

Primary Purpose

Rotator Cuff Rupture, Subacromial Impingement

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Platelet Rich Plasma
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Rupture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • st. Antoniusziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Cuff repair PRP

Cuff repair Control

NEER PRP

NEER Control

Arm Description

Cuff repair Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the cuff repair group

No intervention

Neer Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the NEER surgery group

No intervention

Outcomes

Primary Outcome Measures

Change in VAS pain
Change in painscore measured on a VAS scale

Secondary Outcome Measures

Functional recovery
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
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
At different follow-up moments it is evaluated if patients was able to resume work (6 weeks - 12 weeks - 1 year - 2 years)

Full Information

First Posted
January 9, 2012
Last Updated
April 30, 2014
Sponsor
St. Antonius Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01510639
Brief Title
The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery
Acronym
PRP
Official Title
Results of Subacromial Surgery; The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Rupture, Subacromial Impingement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cuff repair PRP
Arm Type
Experimental
Arm Description
Cuff repair Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the cuff repair group
Arm Title
Cuff repair Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
NEER PRP
Arm Type
Experimental
Arm Description
Neer Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the NEER surgery group
Arm Title
NEER Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in VAS pain
Description
Change in painscore measured on a VAS scale
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Functional recovery
Description
Several questionnaires (RAND-36, SST, and Constant score) and functional tests are measured (Range of motion)
Time Frame
2 years
Title
The amount of patients that had adequate wound healing
Description
At different follow-up moments would healing is evaluated (6 weeks - 12 weeks - 1 year - 2 years)
Time Frame
2 years
Title
The amount of patient who were able to resume their work
Description
At different follow-up moments it is evaluated if patients was able to resume work (6 weeks - 12 weeks - 1 year - 2 years)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra E Flikweert, drs
Organizational Affiliation
St Antoniusziekenhuis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gie Auw yang, Dr
Organizational Affiliation
St. Antoniusziekenhuis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacco Zijl, drs
Organizational Affiliation
St. Antoniusziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
st. Antoniusziekenhuis
City
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs