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.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
reduce pain (VAS score)
Secondary outcome
faster functional recovery
better functional recovery
less wound healing disorders
faster work resumption
Background summary
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 influnce the postoperative course and
lead to extended rehabilitation. This has an infavourable 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 polymorphnuclear leucocytes, macrophages, fibroblasts
and lymphocytes.
Both growth factors stimulate the wound healing and cause improved angiogenesis
and fibroplasie. They also play a role in wound retraction and remodelling.
In animal-experimental models it is proved that the apllication 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 apllicated and both groups are compared
postoperatively.
Study objective
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 design
1. inclusion of the patients
2. informed consent
3. 0- measurement by preoperative score
4. randomization in the operating room
group A = application of the thrombocyte concentratein the subacromial
space after wound closure
group B = control group, no application
Operative method:
- general anesthesia / regional block
- blood sampling and preparation with sterile GPS kit
- open or arthroscopic subacromial decompression
- subacromial application of the thrombocyte concntrate after skin closure (no
drain is left)
- antirotating sling
The thrombocyte concentrate is obtained by taking of 55 ml of blood of the
patient during schoulder surgery. With the GPS system the blood is centrifuged.
After that the Platelet Rich Plasma (PRP) is stored in a sterile way. After
wound closure the PRP is applicated in the subacromial space and the wound is
covered.
Further treatment is identical for both groups.
control takes places on day 1 postoperatively and 2, 6, and 12 weeks
postoperatively. Patients are scored on pain (VAS), mobility, ADL function
(simple shoulder test), UCLA score, SF36(RAND) and Constant Murley score.
Intervention
The application of autologous trombocyte concentrate (PRP). This is a
concentrate with a high amount of trombocytes (containing growth factors),
obtained by centrifuging the paient's own blood. The concentrate is applied
into the subacromial space after closure.
Study burden and risks
With every visit the patient is asked to fill in a questionnaire.
As far as studied, the risks are no different than the risks of the surgery
koekoekslaan 1
3435 cm
NL
koekoekslaan 1
3435 cm
NL
Listed location countries
Age
Inclusion criteria
Age >18 years old, Given informed consent. ;And;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
Diabetis Mellitus
Omarthrosis
AC-arthrosis
Cuff arthropathy
Neurological deficit at the ipsi-lateral extremity
(Wish for) Pregnancy
VAS <2 or VAS >9
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL19106.100.07 |