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The survey study of Dual-Mobility-THA for femoral neck fracture, on the indication and the efficacy/safety

The survey study of Dual-Mobility-THA for femoral neck fracture, on the indication and the efficacy/safety - DM THA Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000010625
Enrollment
50
Registered
2013-07-01
Start date
2013-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Femoral neck fracture

Interventions

None listed

Sponsors

Stryker Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients have diagnosis of femoral neck fracture. 2) Patients for the indication of both of DM THA and BHA. 3) Patients are age 20 or over. 4) Patients, who agree on an IRB-approved, study specific Informed Patient Consent Form 5) Patients are willing and able to comply with postoperative scheduled evaluations

Exclusion criteria

Exclusion criteria: 1) Patients have bacterial infectious disease or have risk highly of bacterial infection. 2) Patients have treatment history of acetabulum/ femur. 3) Patients, who are morbidly obese, defined as having a Body Mass Index (BMI) > 40. 4) Patients who is pregnant female or maybe so. 5) Patients who have a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. 6) Patients with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy), which limits ability to evaluate the safety and efficacy of the device. 7) Patients who are immunologically suppressed or receiving chronic steroids, which limits ability to evaluate the safety and efficacy of the device. 8) Patients who are judged ineligible with reasonable reason by primary doctor.

Design outcomes

Primary

MeasureTime frame
Functional evaluation QOL evaluation

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026