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ADAPT platform no longer supported
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The purpose of this study is to assess whether the Stryker© ADAPT™ augmented-reality platform can assist surgeons in optimizing placement of the lag screw component of the Stryker© Gamma™ cephalomedullary nail.
This will be a prospective, randomized, single-blinded, controlled trial with two treatment cohorts. Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw. Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw. Patients will be blinded to treatment group allocation as will clinicians/researchers during data processing and analysis.
The primary outcome will be tip-apex distance, as measured on anteroposterior and lateral hip radiographs. Secondary outcomes will be position of the lag screw as described by Cleveland et al, operative time, fluoroscopy time, and number of Kirschner wire passes prior to final placement of the lag screw. Additionally, evidence of lag screw cutout on hip radiographs, hip range of motion relative to the contralateral hip, overall mobility, social dependency, and pain level will be assessed at 3 month, 6 month, 1 year, and 2 year follow up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional fluoroscopy | Active Comparator | Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care). |
|
| Stryker© ADAPT™ platform | Experimental | Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™platform to assist with insertion of the lag screw. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stryker© ADAPT™ platform | Device | The ADAPT system is a software platform that utilizes augmented reality to assist surgeons with implant alignment, lag screw length and positioning, and distal interlocking screw placement for cephalomedullary fixation of peritrochanteric femur fractures. |
| Measure | Description | Time Frame |
|---|---|---|
| Tip-apex Distance (TAD) | Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays | Immediate post-operative period |
| Measure | Description | Time Frame |
|---|---|---|
| Lag Screw Position | Lag screw position in the femoral head/neck as described by Cleveland et al. (1959) | Immediate postoperative period |
| Operative Time | The amount of time required to complete the surgical procedure |
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Inclusion criteria:
1. Patients aged 18 years and older with isolated closed peritrochanteric femur fractures who are candidates for surgical fixation with a cephalomedullary nail device
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13849408 | Result | CLEVELAND M, BOSWORTH DM, THOMPSON FR, WILSON HJ Jr, ISHIZUKA T. A ten-year analysis of intertrochanteric fractures of the femur. J Bone Joint Surg Am. 1959 Dec;41-A:1399-408. No abstract available. | |
| 30782395 | Result | Herzog J, Wendlandt R, Hillbricht S, Burgkart R, Schulz AP. Optimising the tip-apex-distance in trochanteric femoral fracture fixation using the ADAPT-navigated technique, a longitudinal matched cohort study. Injury. 2019 Mar;50(3):744-751. doi: 10.1016/j.injury.2019.02.010. Epub 2019 Feb 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Traditional Fluoroscopy | Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care). |
| FG001 | Stryker© ADAPT™ Platform | Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Traditional Fluoroscopy | Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tip-apex Distance (TAD) | Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays | Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention. | Posted | Immediate post-operative period |
|
At time of enrollment; 1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traditional Fluoroscopy | Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wakenda K. Tyler, MD, MPH | Columbia University | 2123059192 | wkt2106@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2020 | Jan 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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Patients will be divided into two treatment arms: cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw. Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™platform to assist with insertion of the lag screw.
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Patients will be blinded to treatment group allocation, as will outcomes assessors. Clinicians performing the procedures will not be blinded.
|
| Traditional fluoroscopy | Radiation | For patients in the control group, traditional fluoroscopy will be utilized for placement of the cephalomedullary nail. |
|
| Intraoperative period |
| Fluoroscopy Time | The amount of fluoroscopy utilized during the surgical procedure as measured in seconds | Intraoperative period |
| K-wire Passes | The total number of K-wire passes prior to final lag screw placement | Intraoperative period |
| Evidence of Lag Screw Cut-out | Evidence of lag screw cut-out as seen on postoperative hip radiographs | 3 months, 6 months, 1 year, and 2 years after surgery |
| Hip Range of Motion | Postoperative range of motion of the affected hip as measured on physical examination | 3 months, 6 months, 1 year, and 2 years after surgery |
| Patient Mobility and Social Dependency | Postoperative patient mobility and social dependency as defined by the Harris Hip Score | 3 months, 6 months, 1 year, and 2 years after surgery |
| Pain Level | Postoperative pain level as defined by the visual analog scale | 3 months, 6 months, 1 year, and 2 years after surgery |
| Stryker© ADAPT™ Platform |
Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.
|
| Secondary | Lag Screw Position | Lag screw position in the femoral head/neck as described by Cleveland et al. (1959) | Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention. | Posted | Immediate postoperative period |
|
|
| Secondary | Operative Time | The amount of time required to complete the surgical procedure | Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention. | Posted | Intraoperative period |
|
|
| Secondary | Fluoroscopy Time | The amount of fluoroscopy utilized during the surgical procedure as measured in seconds | Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention. | Posted | Intraoperative period |
|
|
| Secondary | K-wire Passes | The total number of K-wire passes prior to final lag screw placement | Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention. | Posted | Intraoperative period |
|
|
| Secondary | Evidence of Lag Screw Cut-out | Evidence of lag screw cut-out as seen on postoperative hip radiographs | Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention. | Posted | 3 months, 6 months, 1 year, and 2 years after surgery |
|
|
| Secondary | Hip Range of Motion | Postoperative range of motion of the affected hip as measured on physical examination | Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention. | Posted | 3 months, 6 months, 1 year, and 2 years after surgery |
|
|
| Secondary | Patient Mobility and Social Dependency | Postoperative patient mobility and social dependency as defined by the Harris Hip Score | Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention. | Posted | 3 months, 6 months, 1 year, and 2 years after surgery |
|
|
| Secondary | Pain Level | Postoperative pain level as defined by the visual analog scale | Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention. | Posted | 3 months, 6 months, 1 year, and 2 years after surgery |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Stryker© ADAPT™ Platform | Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D007869 |
| Leg Injuries |