A study of the effectiveness of hip replacement with TNS alloy stems in patients with hip joint dysfunction
| ISRCTN | ISRCTN21241251 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21241251 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 201506-1 |
| Sponsor | Mizuho (Japan) |
| Funder | Mizuho |
- Submission date
- 23/10/2021
- Registration date
- 26/10/2021
- Last edited
- 04/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
A hip replacement is a common type of surgery where a damaged hip joint is replaced with an artificial one (prosthesis). The aim of this study is to investigate whether TiNbSn (TNS) alloy stems hip prostheses can prevent loosening, stress shielding, and thigh pain after hip replacement.
Who can participate?
Patients who are 20 years of age or older, have not had previous hip surgery, and are eligible for surgical treatment due to severe hip joint damage caused by osteoarthritis.
What does the study involve?
Participants undergo total hip replacement surgery using TNS stems. X-rays are taken immediately after the surgery and after 3 weeks, 6 weeks, 3 months, 6 months and 1 year.
What are the possible benefits and risks of participating?
The advantages are that the metal is free from toxic toxins such as vanadium and may prevent bone atrophy (reduction in bone density) and thigh pain after surgery. The disadvantage is that the material has not yet been used for human prostheses, so there are some unknowns. There is a possibility of infection and other problems similar to normal hip joint surgery.
Where is the study run from?
Tohoku University Hospital (Japan)
When is the study starting and how long is it expected to run for?
March 2016 to September 2018
Who is funding the study?
Mizuhos Corporation (Japan)
Who is the main contact?
Dr Yu Mori
yu-mori@med.tohoku.ac.jp
Contact information
Public
1-1 Seiryo-machi
Sendai
9808574
Japan
 ORCID ID |
0000-0002-8225-4690 |
|---|---|
| Phone | +81 (0)22 717 7245 |
| yu-mori@med.tohoku.ac.jp |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter single-arm open-label interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A multicenter, open-label study of total hip arthroplasty with TNS alloy stems in patients with hip dysfunction |
| Study acronym | TNSTHA |
| Study objectives | A TiNbSn (TNS) alloy stem with the functional gradient properties of Young’s modulus and strength could prevent the stress-shielding problem and improve the postoperative outcome of cementless total hip arthroplasty (THA). |
| Ethics approval(s) | Approved 08/03/2016, the research ethics board approval of Tohoku University Hospital (1-1 Seiryo-machi, Sendai, Miyagi, Japan; +81 (0)22 728 4105; ec@rinri.hosp.tohoku.ac.jp), ref: #201506-1 |
| Health condition(s) or problem(s) studied | Hip joint disorder requiring total hip replacement surgery |
| Intervention | 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, 1 year postoperatively. |
| Intervention type | Device |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | TNS alloy stem |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
The inhibition of stress shielding by the TNS stem assessed using radiographic images at 12 months |
| Completion date | 30/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2016 |
| Date of final enrolment | 30/09/2017 |
Locations
Countries of recruitment
- Japan
Study participating centres
Sendai
9808574
Japan
Sendai
9828501
Japan
Osaki
9896183
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository. Anonymization procedures are used to ensure that individuals are not identified. Consent has been obtained from participants for publication and secondary use. As a rule, the researchers do not plan to release the data until the product is commercially available and the resulting paper is published. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/11/2021 | 29/11/2021 | Yes | No | |
| Results article | 03/07/2023 | 04/07/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/07/2023: Publication reference added.
29/11/2021: Publication reference added.
26/10/2021: Trial's existence confirmed by the research ethics board approval of Tohoku University Hospital.
