This study is designed to evaluate the efficacy of autologous P-LRP in the treatment of Achilles tendinopathy, in order to achieve an earlier return to activities.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Earlier return to sport and daily-activities, based upon the VISA-A score.
Secondary outcome
Pain assessment, patient satisfaction, recurrence rate and ultrasound control
Background summary
There is a high prevalence of Achilles tendinopathy in active people and
recreational and professional athletes causing significant inactivity. At this
moment, there is noconsensus on the best form of conservative treatment,
because there is insufficient evidence from randomised controlled trials. The
best accepted treatment is a rehabilitation program, based on eccentric
training. Autologous P-LRP combines platelet concentrate with thrombin and
provides a controlled release of platelet derived growth factors in order to
stimulate and increase cellular activity and healing.
Study objective
This study is designed to evaluate the efficacy of autologous P-LRP in the
treatment of Achilles tendinopathy, in order to achieve an earlier return to
activities.
Study design
A prospective, randomised study
Intervention
Ultrasound guided injection of platelet-leucocyte rich plasma in
Achillestendinopathy.
Study burden and risks
Theoretically blood is at risk for bacterial contamination at the moment of
drawing blood from the patient to fill the preparation unit. From the
preparation process until the application of the P-LRP the whole process is
fully automated. Therefore the risk for bacterial contamination is practically
eliminated compared to conventional preparation techniques.
Michelangelolaan 2
5623 EJ
NL
Michelangelolaan 2
5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Clinical diagnosis of Achillestendinopathie (see also page 16 of protocol).
Established diagnosis of maximum 3 months.
Exclusion criteria
Tendonruptures
History of ankle or Achillestendon operation
Other explanations for pain Achillestendon (i.e. arthritis)
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 | NL26947.060.09 |