Delta Xtend reversed shoulder prosthesis.

Four-part fractures of the proximal humerus; conservative treatment or reversed type shoulder prosthesis.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25375

Enrollment

Registered

2010-01-28

Start date

2010-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

four-part fracture, conservative treatment, reversed shoulder prosthesis

Interventions

A 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 (

Eligibility

Inclusion criteria

Inclusion criteria: 1. > 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
Difference in Constant Murley Score at 12 months between the intervention and historical control group.	—

Secondary

Measure	Time frame
1. 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.	—

Measure

Time frame

1. 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.

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Contacts

Public ContactS. Grinsven, van

Wagnerlaan 55

SvanGrinsven@Alysis.nl+31 (0)88 0056366

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)