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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair

NCT01424969

Rotator Cuff Tear Arthropathy

COMPLETED

Impact of Autologous Platelet Rich Plasma on Healing of Rotator Cuff Repairs

NCT01000935

Rotator Cuff Pathology

COMPLETED PHASE2

Treatment of Rotator Cuff Tears With Platelet Rich Plasma

NCT06481046

Rotator Cuff Tears Rotator Cuff Tendinitis

WITHDRAWN NA

Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing

NCT00198185

Rotator Cuff Tendon Injuries

WITHDRAWN PHASE3

Platelet Rich Plasma on Rotator Cuff Repair

NCT01029574

Rotator Cuff Tears

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotator Cuff Rupture Subacromial Impingement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cuff repair PRP

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

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type BIOLOGICAL

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.

Cuff repair Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

NEER PRP

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

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type BIOLOGICAL

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.

NEER Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No