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A study of the effectiveness of hip replacement with TNS alloy stems in patients with hip joint dysfunction

A multicenter, open-label study of total hip arthroplasty with TNS alloy stems in patients with hip dysfunction

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21241251
Enrollment
40
Registered
2021-10-26
Start date
2016-04-01
Completion date
Unknown
Last updated
2023-07-18

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

Conditions

Hip joint disorder requiring total hip replacement surgery Musculoskeletal Diseases

Interventions

Total hip arthroplasties using the TNS alloy stem are performed in cases that meet the inclusion criteria. Radiographs are taken immediately after the surgery, at 3 weeks, 6 weeks, 3 months, 6 months,

Sponsors

Mizuho (Japan)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients over 20 years of age 2. Preoperative diagnosis of osteoarthritis, avascular necrosis, or rheumatoid arthritis 3. Consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Previous operation (total hip arthroplasty, osteotomy, tenotomy around hip joint) 2. Bilateral hip disorder 3. Rheumatoid arthritis of Charnley category C (multiple joint disease or other disease limiting mobility) 4. Past history of deep venous thrombosis or pulmonary embolism, metal allergy, severe obesity (Body Mass Index >35.0 kg/m²) 5. Severe diabetes mellitus 6. Infection around the hip joint

Design outcomes

Primary

MeasureTime frame
1. Clinical outcomes assessed using the Japanese Orthopaedic Association (JOA) hip scores before the surgery, 6 weeks, 3 months, 6 months, and 1 year postoperatively 2. Pain, activities of daily life and mental health status assessed using the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) before the surgery, 3 months, 6 months, and 1 year postoperatively

Secondary

MeasureTime frame
The inhibition of stress shielding by the TNS stem assessed using radiographic images at 12 months

Countries

Japan

Contacts

Public ContactYu Mori
yu-mori@med.tohoku.ac.jp+81 (0)22 717 7245

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026