Which head element is more effective for hip fracture implants to prevent implant-related failures? A helical blade or a lag screw
| ISRCTN | ISRCTN45341843 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45341843 |
- Submission date
- 13/12/2022
- Registration date
- 24/12/2022
- Last edited
- 04/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Early fixation and rehabilitation is the gold standard treatment for intertrochanteric femur fractures. Cement augmentation through perforated head elements has been developed to avoid postoperative complications such as cut-outs or cut-through. The purpose of this study was to compare two head elements in terms of cement distribution using computed tomography (CT) and to examine their initial fixation and clinical outcomes.
Who can participate?
Adult patients with proximal femur fractures
What does the study involve?
Internal fixation with a trochanteric fixation nail advanced (TFNA) helical blade cement augmentation is compared with a TFNA lag screw.
What are the possible benefits and risks of participating?
Possible benefits of participation are frequent clinical evaluation and accurate radiographic investigation of the patient's fractures. Almost no risks are anticipated.
Where is the study run from?
Shin Kyoto Minami Hospital (Japan)
When is the study starting and how long is it expected to run for?
September 2020 to August 2022
Who is funding the study?
Shin Kyoto Minami Hospital (Japan)
Who is the main contact?
Sadaki Mitsuzawa, sadaki_mitsuzawa@kcho.jp (Japan)
Contact information
Scientific
Minatojimaminamimachi 2-1-1
Kobe
6500047
Japan
 ORCID ID |
0000-0002-6766-5512 |
|---|---|
| Phone | +78-302-4321 |
| sadaki_mitsuzawa@kcho.jp |
Study information
| Study design | Randomized parallel-assignment study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Which head element is more effective for cement augmentation of trochanteric fixation nail advanced implants? Helical blade versus lag screw |
| Study hypothesis | The cement position and volume might differ, but the stability and clinical results will be similar between the two groups of elderly patients who had intertrochanteric fractures treated with either a trochanteric fixation nail advanced (TFNA) helical blade or a TFNA lag screw |
| Ethics approval(s) | 1. Approved 09/02/2021, Ethics Committee of Shin Kyoto Minami Hospital (94 Shichijo Goshonouchi Kitamachi, Shimogyo Ward, Kyoto, 600-8861, Japan; +78 322 3344; minami-ikyoku@hello.odn.ne.jp), ref: SHIN20-019 2. Approved 17/03/2021, Ethics Committee of Rakuwakai Otowa Hospital (2 Otowa Chinjicho, Yamashina-ku, Kyoto, 607-8062, Japan; +75 593 4111; sandu-ionut@rakuwa.or.jp), ref: RAKUOTO-RIN21-016 |
| Condition | Proximal femur fractures |
| Intervention | Elderly patients who had intertrochanteric fractures were treated with a trochanteric fixation nail advanced (TFNA) helical blade (Blade group) or a TFNA lag screw (Screw group). In both groups, 4.2 ml of cement was injected under an image intensifier. In both groups, maximum penetration depth was measured. Changes in radiographic parameters and clinical outcomes such as the Parker score and visual analog scale (VAS) were also recorded. Other tests included mechanical stability after surgery, postoperative pain and the early phase of rehabilitation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Amount of cement distribution measured using CT scan on the day after the surgery |
| Secondary outcome measures | Clinical outcome measured using a visual analog scale (VAS) scoring and Parker score on postoperative day 14 |
| Overall study start date | 01/09/2020 |
| Overall study end date | 30/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 29 |
| Participant inclusion criteria | Proximal femur fractures |
| Participant exclusion criteria | 1. Occult fracture detected by magnetic resonance imaging only 2. Pathological fracture 3. Presence of pre-existing implants 4. Multiple trauma or additional fracture that would affect the patient’s postoperative rehabilitation |
| Recruitment start date | 01/11/2020 |
| Recruitment end date | 30/04/2021 |
Locations
Countries of recruitment
- Japan
Study participating centres
Kyoto
600-8876
Japan
Kyoto
607-8062
Japan
Sponsor information
Hospital/treatment centre
94 Shichijo Goshonouchi Kitamachi
Shimogyo-Ku
Kyoto City
600-8861
Japan
| Phone | +78-322-3344 |
|---|---|
| minami-ikyoku@hello.odn.ne.jp |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Sadaki Mitsuzawa, sadakimitsuzawa@gmail.com The type of data that will be shared: Excel file Consent from participants is required |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/07/2023 | 04/07/2023 | Yes | No |
Editorial Notes
04/07/2023: Publication reference and total final enrolment added.
23/12/2022: Trial's existence confirmed by the Ethics Committee of the Medical Corporation Kenkokai Shin-Kyoto Minami Hospital.
