Our primary objective is to compare the short-term (one-year follow-up) clinical results of the DePuy Delta Xtend reversed shoulder prosthesis with conservative treatment, in the management of displaced four-part fractures of the proximal humerus of…
ID
Source
Brief title
Condition
- Bone and joint injuries
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in Constant Murley Score at 12 months between the intervention and
historical control group.
Secondary outcome
Constant Murley score at 3 months. Visual analogue scale (VAS) for pain and
impairment, range of motion (ROM), MecMesin myometer measurement of abduction
force in Newton, and postoperative standing AP, axial and SOV radiographs at 3
and 12 months. Dutch simple shoulder test at 12 months.
Perioperative complications, postoperative complications and adverse events
will be counted for type (% of total events) at
12 months.
Background summary
Displaced four-part fractures are among the most severe injuries and are
positively correlated with age and osteoporosis. The optimal treatment for
displaced four-part fractures is disputed. Recent systematic reviews [6, 16,
17] emphasised that the limited evidence available does not confirm that
surgery (i.e. hemiprosthesis) is preferable to conservative treatment in
displaced fractures and concluded that published data are inadequate for
evidence-based decision making. In a few recent studies [18, 19] promising
results, in the management of four-part proximal humerus fractures, are
mentioned with a reverse prosthesis. To our knowledge, the Delta Xtend reversed
shoulder prosthesis has never been compared to conservative treatment in the
management of displaced 4-part fractures of the proximal humerus.
Study objective
Our primary objective is to compare the short-term (one-year follow-up)
clinical results of the DePuy Delta Xtend reversed shoulder prosthesis with
conservative treatment, in the management of displaced four-part fractures of
the proximal humerus of elderly.
Study design
Prospective single arm trial (Depuy, Delta Xtend reversed shoulder prosthesis)
versus historical control group (conservative treatment).
Intervention
A Delta Xtend reversed shoulder prosthesis will be inserted in all patients.
All patients will receive a clinical and post clinical standardised
rehabilitation program.
Study burden and risks
The limited evidence available does not confirm that surgery (i.e.
hemiprosthesis) is preferable to conservative treatment in displaced fractures.
In recent studies promising results are mentioned with a reversed prosthesis.
The potential risk of a Delta Xtend prosthesis (reversed shoulder prosthesis)
is no different than with a hemiprosthesis, which is a fully accepted treatment
of four-part fractures. The extra burden associated with participation in this
study are the Constant Murley Score, the MecMesin Myometer abduction force test
and the radiographs at 3 and 12 months and the Dutch simple shoulder test at 12
months.
Wagnerlaan 55
6800 TA Arnhem
NL
Wagnerlaan 55
6800 TA Arnhem
NL
Listed location countries
Age
Inclusion criteria
* > 70 years of age
* 4-part fracture confirmed by 2 orthopaedic surgeons on X-ray
* Informed consent / patient information
* Mentally alert and physically fit (ASA-group 1-3) for surgery and rehabilitation
* The patient agrees to comply with postoperative clinical and radiographic evaluations
and the required rehabilitation regime
Exclusion criteria
* Pathological or complex fracture
* Pathology of the contra lateral shoulder
* Dementia
* Active infection
* Axillary nerve palsy
* A deficient deltoid muscle
* Abuse problems
* Unable to understand the meaning of informed consent, the patient information, instructions in
Dutch and follow the rehabilitation protocol
* The subject has participated in clinical trials evaluating investigational devices,
pharmaceuticals or biologics within 3 months of enrolment in the study
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 |
|---|---|
| Other | Het is aangemeld in het Nederlands Trial Register. We wachten nog op het registratienummer |
| CCMO | NL30609.091.10 |