Hip Fractures
Conditions
Keywords
Peritrochanteric femur fractures
Brief summary
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.
Detailed description
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.
Interventions
DEVICEStryker© ADAPT™ platform
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.
RADIATIONTraditional fluoroscopy
For patients in the control group, traditional fluoroscopy will be utilized for placement of the cephalomedullary nail.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients will be blinded to treatment group allocation, as will outcomes assessors. Clinicians performing the procedures will not be blinded.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
1. Patients with open peritrochanteric femur fractures or multiple injuries (i.e., polytrauma) 2. Patients with peritrochanteric femur fractures better treated with a device other than a cephalomedullary nail, as determined by the attending orthopedic surgeon 3. Patients less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tip-apex Distance (TAD) | Immediate post-operative period | Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Intraoperative period | The amount of time required to complete the surgical procedure |
| Fluoroscopy Time | Intraoperative period | The amount of fluoroscopy utilized during the surgical procedure as measured in seconds |
| K-wire Passes | Intraoperative period | The total number of K-wire passes prior to final lag screw placement |
| Lag Screw Position | Immediate postoperative period | Lag screw position in the femoral head/neck as described by Cleveland et al. (1959) |
| Hip Range of Motion | 3 months, 6 months, 1 year, and 2 years after surgery | Postoperative range of motion of the affected hip as measured on physical examination |
| Patient Mobility and Social Dependency | 3 months, 6 months, 1 year, and 2 years after surgery | Postoperative patient mobility and social dependency as defined by the Harris Hip Score |
| Pain Level | 3 months, 6 months, 1 year, and 2 years after surgery | Postoperative pain level as defined by the visual analog scale |
| Evidence of Lag Screw Cut-out | 3 months, 6 months, 1 year, and 2 years after surgery | Evidence of lag screw cut-out as seen on postoperative hip radiographs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 6 |
| 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. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Traditional Fluoroscopy | Total | Stryker© ADAPT™ Platform |
|---|---|---|---|
| Age, Continuous | 82.7 years STANDARD_DEVIATION 12.5 | 82.3 years STANDARD_DEVIATION 13 | 82.0 years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 10 Participants | 4 Participants |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
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
Time frame: Immediate post-operative period
Population: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Secondary
Evidence of Lag Screw Cut-out
Evidence of lag screw cut-out as seen on postoperative hip radiographs
Time frame: 3 months, 6 months, 1 year, and 2 years after surgery
Population: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Secondary
Fluoroscopy Time
The amount of fluoroscopy utilized during the surgical procedure as measured in seconds
Time frame: Intraoperative period
Population: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Secondary
Hip Range of Motion
Postoperative range of motion of the affected hip as measured on physical examination
Time frame: 3 months, 6 months, 1 year, and 2 years after surgery
Population: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Secondary
K-wire Passes
The total number of K-wire passes prior to final lag screw placement
Time frame: Intraoperative period
Population: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Secondary
Lag Screw Position
Lag screw position in the femoral head/neck as described by Cleveland et al. (1959)
Time frame: Immediate postoperative period
Population: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Secondary
Operative Time
The amount of time required to complete the surgical procedure
Time frame: Intraoperative period
Population: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Secondary
Pain Level
Postoperative pain level as defined by the visual analog scale
Time frame: 3 months, 6 months, 1 year, and 2 years after surgery
Population: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Secondary
Patient Mobility and Social Dependency
Postoperative patient mobility and social dependency as defined by the Harris Hip Score
Time frame: 3 months, 6 months, 1 year, and 2 years after surgery
Population: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.