Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521671
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Early Migration of Internal Fixation Implants for Femoral Neck Fractures in Young Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Migration of Internal Fixation Implants for Femoral Neck Fractures in Young Adults A RCT Using Radiostereometric Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the clinical trial is to assess a novel implant Dynaloc Swemac for internal fixation of femoral neck fractures and compare it to standard treatment with cannulated cancellous screws using AutoRSA Radiostereometric analysis
The main question it aims to answer is
Is internal fixation with the novel implant consisting of three angle stable screws locked together by a plate superior to internal fixation with cancellous screws in young adults under 65 years of age
Researchers will assess postoperative complications and functional outcomes as well as implant migration using AutoRSA
The participants will be treated with either Dynaloc or cannulated cancellous screws and followed up at 6 weeks 12 weeks 6 months and 12 months
The main question it aims to answer is
Is internal fixation with the novel implant consisting of three angle stable screws locked together by a plate superior to internal fixation with cancellous screws in young adults under 65 years of age
Researchers will assess postoperative complications and functional outcomes as well as implant migration using AutoRSA
The participants will be treated with either Dynaloc or cannulated cancellous screws and followed up at 6 weeks 12 weeks 6 months and 12 months
Detailed Description:
Objective The overall purpose is to assess a novel implant Dynaloc Swemac for internal fixation of femoral neck fractures and compare it to treatment with cannulated cancellous screws CCS The hypothesis is that internal fixation with the novel implant consisting of three angle stable screws locked together by a plate is superior to internal fixation with CCS using fracture migration as the primary outcome
Both Dynaloc and CCS are CE-marked medical devices used as intended by the manufacturer
Trial design The study is designed as a single blinded randomised controlled trial RCT with Radiostereometric Analysis RSA
Interventions Patients will be randomised to internal fixation with CCS or a novel implant designed to minimise fracture migration Dynaloc Swemac The standard internal fixation can include either two or three CCS The operation procedures will be according to the manufacturers surgical techniqueinstructions for use
Sample size calculation Primary and secondary outcomes include shortening of the femoral neck at 6 weeks 12 weeks and 1 year A clinical relevance can be expected at 5mm shortening of the femoral neck Femoral neck shortening in the group randomised to internal fixation with CCS is expected to be 53mm SD 45mm at 6 weeks
Using power 09 significance level 005 and expecting femoral neck shortening of maximum 1mm for the angle stable screws Dynaloc compared with 53mm SD 45mm using 2-3 cancellous screws a total sample size of N50 can be calculated N25group
We expect approx 10 loss to follow up and will therefore include a total of 54 patients
Randomizationallocation If informed consent is provided eligible patients can be enrolled in the study
Patients will be entered into an electronic database and randomised to either CCS or Dynaloc using blocks of n4 and n6 and will be stratified based on the Garden classification Garden 1-2 or 3-4 to account for fracture displacement and stratified based on hospital of admission The patients will be stratified according to the Garden classification as studies show significantly higher failure rates in Garden type 3 and 4 The operating surgeon will contact a central coordinator who performs the randomisation prior to the surgery Therefore the surgeon knows which implant to use before entering the operating theatre
Blinding The implant and outcome will be blinded to patients involved in the trial A standard phrase for the surgery will be used
Data Collection Project staff will collect data CT scans and radiostereometric x-rays and will analyse using AutoRSA Screening will be performed by the admitting doctor Baseline data will be collected during admission and will be entered directly into REDcap by project personnel Questionnaires will be sent directly to the patients using REDcap and the answers will be automatically uploaded into REDcap At follow ups project personnel will see the patients in the outpatient clinic and enter data directly into REDcap
Statistical methods Data will be analysed using computerised statistical software The data distribution will be assessed and data presented accordingly Continuous data will be analysed using Linear Mixed Model statistics and categorical data will be compared using the χ2 test or the Fisher exact test
A p-value of 005 will be considered statistically significant The postoperative complication rates will be defined as the sum of the individual rates of complications and reoperations Mortality will be analysed using Cox-regression
Both Dynaloc and CCS are CE-marked medical devices used as intended by the manufacturer
Trial design The study is designed as a single blinded randomised controlled trial RCT with Radiostereometric Analysis RSA
Interventions Patients will be randomised to internal fixation with CCS or a novel implant designed to minimise fracture migration Dynaloc Swemac The standard internal fixation can include either two or three CCS The operation procedures will be according to the manufacturers surgical techniqueinstructions for use
Sample size calculation Primary and secondary outcomes include shortening of the femoral neck at 6 weeks 12 weeks and 1 year A clinical relevance can be expected at 5mm shortening of the femoral neck Femoral neck shortening in the group randomised to internal fixation with CCS is expected to be 53mm SD 45mm at 6 weeks
Using power 09 significance level 005 and expecting femoral neck shortening of maximum 1mm for the angle stable screws Dynaloc compared with 53mm SD 45mm using 2-3 cancellous screws a total sample size of N50 can be calculated N25group
We expect approx 10 loss to follow up and will therefore include a total of 54 patients
Randomizationallocation If informed consent is provided eligible patients can be enrolled in the study
Patients will be entered into an electronic database and randomised to either CCS or Dynaloc using blocks of n4 and n6 and will be stratified based on the Garden classification Garden 1-2 or 3-4 to account for fracture displacement and stratified based on hospital of admission The patients will be stratified according to the Garden classification as studies show significantly higher failure rates in Garden type 3 and 4 The operating surgeon will contact a central coordinator who performs the randomisation prior to the surgery Therefore the surgeon knows which implant to use before entering the operating theatre
Blinding The implant and outcome will be blinded to patients involved in the trial A standard phrase for the surgery will be used
Data Collection Project staff will collect data CT scans and radiostereometric x-rays and will analyse using AutoRSA Screening will be performed by the admitting doctor Baseline data will be collected during admission and will be entered directly into REDcap by project personnel Questionnaires will be sent directly to the patients using REDcap and the answers will be automatically uploaded into REDcap At follow ups project personnel will see the patients in the outpatient clinic and enter data directly into REDcap
Statistical methods Data will be analysed using computerised statistical software The data distribution will be assessed and data presented accordingly Continuous data will be analysed using Linear Mixed Model statistics and categorical data will be compared using the χ2 test or the Fisher exact test
A p-value of 005 will be considered statistically significant The postoperative complication rates will be defined as the sum of the individual rates of complications and reoperations Mortality will be analysed using Cox-regression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None