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Accolade TMZF Femoral Stem with Trident Ceramic on Ceramic and Crossfire Polyethylene Prospective Randomized Comparison Study

Accolade TMZF Femoral Stem with Trident Ceramic on Ceramic and Crossfire Polyethylene Prospective Randomized Comparison Study - Prospective Randomized Comparison Study of Accolade TMZF with 2 Different Bearing Choices.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017497
Enrollment
110
Registered
2015-05-11
Start date
2009-12-25
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

HIP Osteoarthritis,Avascular,Nocrosis,and THA for Femoral Neck Fracture Cases

Interventions

Accolade TMZF Stem Trident HA shell

Sponsors

Shonan Kamakura Jiont Reconstruction Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Patients have diagnosis of osteoarthritis,avascular necrosis, or femoral neck fracture,and are candidates for primary THA 2) Patients have diagnosis of other symptoms and are candidates for THA

Exclusion criteria

Exclusion criteria: 1) Patients need cement fixation of prosthesis 2) Patients are candidates for Revision THA 3) Patients have diagnosis of Rheumatoid Arthritis 4) Patients have infectious disease or have risk of infection 5) Patients who have a neuromuscular or neurosensory dificiency, which limits ability to evaluate the safety and efficacy of the device 6) Patients who are judged ineligible by primary doctor cannot conduct standard rehabilitation 7) Patients are 66 years old or over 8) Male patients 9) Patients who are judged ineligible with reasonable reason by primary doctor

Design outcomes

Primary

MeasureTime frame
Fixation of Prosthesis (Engh Classification), Position of Prosthesis (Alignment and depth), Radiolucent Line (Gruen Zone for Femur and Delee Charnley Zone for Acetabulum), and Osteolysis(Both Femur and Acetabulum)

Secondary

MeasureTime frame
JOA Score,Thigh Pain, Trendelenburg's Sign,Squeaking,and Other Complications

Countries

Japan

Contacts

Public ContactRiichiro Tsukamoto

Shonan Kamakura Jiont Reconstruction Center Department of Orthopaedic Surgery

izumi.kokubun@tokushukai.jp0467-47-2377

Outcome results

None listed

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