This study is designed to evaluate the efficacy of autologous P-LRP in the treatment of lateral elbow tendinopathy, in order to achieve an earlier return to activities and fit to play.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Earlier return to activities, confirmed by Nirschl-classification and
DASH-scores.
Secondary outcome
Pain assessment, patient satisfaction, recurrence rates and ultrasound control.
Background summary
Laterale elbow tendinopathy (tenniselbow) is a common soft tissue injury. It
causes pain and loss of function and therefore considerable morbidity and
financial cost. At this moment there is noconsensus on the best form of
treatment and numerous methods and interventions have been used, but high level
evidence is lacking. Autologous P-LRP 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 lateral elbow tendinopathy, in order to achieve an earlier return
to activities and fit to play.
Study design
A prospective, randomised trial
Intervention
Ultrasound guided injection of platelet-leucocyte rich plasma in lateral elbow
tendinopathy.
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
Nederland
Michelangelolaan 2
5623 EJ
Nederland
Listed location countries
Age
Inclusion criteria
Clinical diagnosis of lateral elbow tendinopathy (see also page 16 of protocol).
Established diagnosis of 3 months.
Exclusion criteria
Tendonruptures
History of elbowoperation
Other explanations for pain lateral elbow (i.e. arthrosis)
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 | NL27357.060.09 |