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Delta Xtend reversed shoulder prosthesis.


- candidate number7699
- NTR NumberNTR2186
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jan-2010
- Secondary IDs2010/039 / NL30609.091.10 ; METC / ABR
- Public TitleDelta Xtend reversed shoulder prosthesis.
- Scientific TitleFour-part fractures of the proximal humerus; conservative treatment or reversed type shoulder prosthesis.
- ACRONYMDelta Xtend
- hypothesisOur 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.
- Healt Condition(s) or Problem(s) studiedConservative treatment, Reversed shoulder prothesis, Four-part fracture
- Inclusion criteria1. > 70 years of age;
2. 4-part fracture confirmed by 2 orthopaedic surgeons on X-ray;
3. Informed consent / patient information;
4. Mentally alert and physically fit (ASA-group 1-3) for surgery and rehabilitation;
5. The patient agrees to comply with postoperative clinical and radiographic evaluations and the required rehabilitation regime.
- Exclusion criteria1. Pathological or complex fracture;
2. Pathology of the contra lateral shoulder;
3. Dementia;
4. Active infection;
5. Axillary nerve palsy;
6. A deficient deltoid muscle;
7. Abuse problems;
8. Unable to understand the meaning of informed consent, the patient information, instructions in Dutch and follow the rehabilitation protocol ;
9. The subject has participated in clinical trials evaluating investigational devices, pharmaceuticals or biologics within 3 months of enrolment in the study.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2010
- planned closingdate1-feb-2013
- Target number of participants25
- InterventionsA Delta Xtend reversed shoulder prosthesis will be inserted in all patients. All patients will receive a clinical and post clinical standardised rehabilitation program.

Prospective single arm trial (Depuy, Delta Xtend reversed shoulder prosthesis) versus historical control group (conservative treatment).
- Primary outcomeDifference in Constant Murley Score at 12 months between the intervention and historical control group.
- Secondary outcome1. Constant Murley score at 3 months;
2. Visual analogue scale (VAS) for pain and impairment;
3. Range of motion (ROM);
4. MecMesin myometer measurement of abduction force in Newton;
5. Postoperative standing AP;
6. Axial and SOV radiographs at 3 and 12 months;
7. 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.
- TimepointsFollow-up at 1 week, 6 weeks, 3 months and 12 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S. Grinsven, van
- CONTACT for SCIENTIFIC QUERIES C.J.M. Loon, van
- Sponsor/Initiator Rijnstate Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Johnson & Johnson
- PublicationsN/A
- Brief summaryBackground of the study:
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 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 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.

Objective of the study:
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).

Study population:
Patients diagnosed with displaced four-part fracture, > 70 years old.

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.

Primary study parameters/outcome of the study:
Difference in Constant Murley Score at 12 months between the intervention and historical control group.

Secundary study parameters/outcome of the study (if applicable):
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.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
- Main changes (audit trail)
- RECORD28-jan-2010 - 28-jan-2011


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