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

Phase 3

Completed

• Conditions: Hip joint disorder requiring total hip replacement surgery; Musculoskeletal Diseases

• Registration Number: ISRCTN21241251
• Lead Sponsor: Mizuho (Japan)

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34836525/ (added 29/11/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37400903/ (added 04/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-09-30
• Study Start: 2021-10-26
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified