Application of a novel mixed reality navigation technology in the distal interlocking of femoral intramedullary nails
| ISRCTN | ISRCTN34394615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34394615 |
| Secondary identifying numbers | National Natural Science Foundation of China: 82172441, Suzhou City Major Disease Multicenter Clinical Research Project: DZXYJ202312, Special Funding for Jiangsu Province Science and Technology Plan: BE2023737 and BE2022718, Kunshan Key Research and Development Program Project: KS2313, Gusu Health Talent Plan Scientific Research Project: GSWS2022109 |
- Submission date
- 17/08/2024
- Registration date
- 04/09/2024
- Last edited
- 02/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study aims to test a new technique involving Mixed Reality (MR) for treating femoral fractures (fractures in the thigh bone). The research team have developed an MR-based three-dimensional spatial positioning technique that may offer advantages over conventional methods such as reducing radiation exposure, providing stereoscopic in-situ visualizations, reducing drilling attempts, and improving hand-eye coordination.
Who can participate?
Adult patients aged 18 to 65 years old with femoral fractures (proximal femoral or femoral shaft fracture) who are undergoing surgery at the Affiliated Kunshan Hospital of Jiangsu University (AKHJU)
What does the study involve?
The study involves two groups: the Mixed Reality Navigation Group (MR) and the Conventional Mechanical Guide Distal Locking Group (Control). The MR group will be treated with the new MR-based technique, while the Control group will undergo the standard treatment. Participants will be randomly assigned to these groups.
What are the possible benefits and risks of participating?
The new MR technique may potentially improve surgical outcomes and reduce complications. However, as with any surgical intervention, there are risks associated with surgery. Participants will receive detailed information about potential benefits and risks before consenting to participate.
Where is the study run from?
The study is run by the Affiliated Kunshan Hospital of Jiangsu University (AKHJU).
When is the study starting and how long is it expected to run for?
July 2023 to July 2026
Who is funding the study?
1. National Natural Science Foundation of China
2. Suzhou City Major Disease Multicenter Clinical Research Project
3. Special Funding for Jiangsu Province Science and Technology Plan (Key Research and Development Program for Social Development)
4. Kunshan Key Research and Development Program Project
5. Gusu Health Talent Plan Scientific Research Project
Who is the main contact?
Dr Ke Lu, sgu8434@sina.com
Contact information
Public, Scientific, Principal Investigator
Affiliated Kunshan Hospital of Jiangsu University, No. 566 East of Qianjin Road
Suzhou
215300
China
 ORCID ID |
0000-0002-0029-7874 |
|---|---|
| Phone | 0086-0512-57532362 |
| sgu8434@sina.com |
Study information
| Study design | Single-center interventional open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Application of a novel mixed reality navigation technology in distal interlocking of femoral intramedullary nails: a prospective cohort study |
| Study objectives | The proposed mixed reality (MR)-based three-dimensional spatial positioning technique, compared to conventional approaches, is hypothesized to have several anticipated advantages, including elimination of radiation exposure, provision of stereoscopic in-situ visualizations, reduction in drilling attempts, and enhancement of hand-eye coordination. |
| Ethics approval(s) |
Approved 15/09/2023, Ethics Committee of the Affiliated Kunshan Hospital of Jiangsu University (Affiliated Kunshan Hospital of Jiangsu University, No. 566 East of Qianjin Road, Suzhou, 215300, China; +86 0512 57027807; Ksrmyyiec@163.com), ref: 2023-04-001-H01 |
| Health condition(s) or problem(s) studied | Femoral fractures (proximal femoral or femoral shaft fracture) |
| Intervention | This study primarily introduces a novel Mixed Reality (MR) navigation system and single-fluoroscopy calibration for distal interlocking of Intramedullary Nails (IMNs). A retrospective cohort study was conducted from July to December 2023 to assess the efficacy of the MR navigation system. Ten participants with femoral fractures suitable for IMN treatment were recruited. These data were analyzed for initial distal interlocking outcomes, including success rates, and followed up at 1, 2, 3, 6, 9, and 12 months post-operation to evaluate fracture healing and complications. This is an interventional study involving two groups: the MR navigation system and the Conventional Mechanical Guide Distal Locking Group (Control). Both groups consist of patients with femoral fractures (proximal femoral or femoral shaft fracture) who have undergone surgery at the Affiliated Kunshan Hospital of Jiangsu University (AKHJU). In the MR group, a total of 40 patients will be treated using an MR-based three-dimensional spatial positioning technique for the distal interlocking holes of femoral intramedullary nails (IMN). This technique allows for automatic and precise calculation of the MR-guided axis in the three-dimensional space. On the other hand, in the Control group, another set of 40 patients will undergo conventional mechanical guide distal locking, which is the standard treatment for such cases. The allocation of patients to the two groups is determined by a random number sequence generated by a computer-based random number algorithm, as designed by the study statistician. Exclusion criteria for the study include severe trauma that precludes safe surgical intervention, unwillingness to participate in the MR navigation-guided surgery, contraindications for surgery, severe comorbid conditions that could impact the outcome or safety of the surgical procedure, and pre-existing conditions that could interfere with the use of MR technology, such as severe visual or cognitive impairments. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | MR-based three-dimensional spatial positioning technique |
| Primary outcome measure | The initial hit success rate is measured using data collected during the procedures as the number of successful cases on the first attempt to lock the distal holes during the process of using the MR-based three-dimensional spatial positioning technique for the distal interlocking holes of femoral IMNs, divided by the total number of cases attempting this method, at the timepoint immediately following the procedure |
| Secondary outcome measures | Hit success rate is measured using data collected during the procedures as the number of successful cases when attempting to lock the distal holes using the MR-based three-dimensional spatial positioning technique for the distal interlocking holes of femoral IMNs, divided by the total number of cases in the Mixed Reality Navigation Group (MR), at the timepoint immediately following the procedure |
| Overall study start date | 01/07/2023 |
| Completion date | 31/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Patients with a primary femoral fracture diagnosis, including proximal femoral fracture or femoral shaft fracture. 2. Suitable for intramedullary nailing (IMN) treatment. 3. Willing to undergo mixed reality (MR) navigation-guided surgery. |
| Key exclusion criteria | 1. Severe trauma that precludes safe surgical intervention 2. Patients unwilling to participate in the MR navigation-guided surgery 3. Patients with contraindications for surgery 4. Individuals with severe comorbid conditions that could impact the outcome or safety of the surgical procedure 5. Patients with pre-existing conditions that could interfere with the use of MR technology, such as severe visual or cognitive impairments |
| Date of first enrolment | 01/07/2024 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Suzhou
215300
China
Sponsor information
Hospital/treatment centre
Affiliated Kunshan Hospital of Jiangsu University
No. 566 East of Qianjin Road
Suzhou
215300
China
| Phone | +86-0512-57532362 |
|---|---|
| lichong1705@163.com | |
| Website | https://www.ksrmyy.org/index.html?eqid=8a03eb04000b5175000000056491524e |
"ROR" |
https://ror.org/01kzsq416 |
Funders
Funder type
Not defined
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/07/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from(Ke Lu sgu8434@sina.com). All de-identified individual participant data, including baseline variables and clinical outcomes, will be shared. These data will be made available within one year after the completion of the study and will remain accessible for at least five years. Consent for data sharing has been obtained from all participants, and the data will be de-identified to protect participant privacy. Currently, there are no known ethical or legal restrictions that would prevent the sharing of these data. Researchers with a reasonable request for data usage are encouraged to submit their requests. All data requests will be reviewed, and requesters may be required to provide a methodologically sound proposal for how they intend to use the data. |
Editorial Notes
27/08/2024: Study's existence confirmed by the Ethics Committee of the Affiliated Kunshan Hospital of Jiangsu University.
