Gait Biomechanics, Hip Arthroplasty Replacement, Surgeon Physiologic Stress
Conditions
Brief summary
Placing the parts of a hip replacement requires substantial force. This can lead to additional stress on the surgeon as well as the bone. A device was developed to help reduce this stress. This study aims to see whether this device impacts implant positioning and the surrounding bone in patients 70 years and older. It also will investigate surgeon efficiency and how patients walk after surgery.
Detailed description
Preparation of the femoral canal and acetabulum impaction have traditionally been accomplished with the use of a mallet and manual instruments. During manual broaching or impaction, force is transmitted with each mallet strike, which distributes horizontal forces to cortical bone. Excessive force and malalignment of instruments can lead to intraoperative fractures, or unrecognized fractures contributing to early failure of the total hip arthroplasty (THA). This risk can be elevated in direct anterior (DA) THA when exposure is compromised due to the minimally invasiveness of the approach. The advent of powered broaching devices which provide a consistent force and are more ergonomic, now provide an alternative to manual techniques. Despite its proposed benefits, it has yet to achieve widespread adoption. The study aims to assess whether the use of a powered broaching device (KINCISE2) has an impact on intraoperative or early postoperative femoral or acetabular fractures in patients 70 years or older, when compared to traditional manual techniques in DA THA. Patients will be subgrouped based on femoral/acetabular bone quality/morphology. Secondary outcomes measured will consist of femoral canal fil, femoral version and acetabular cup-floor gap and gait analysis measures via markerless motion capture. Surgical efficiency will be measured via operative time, broaching/impaction time and surgical stress via biometric monitoring. PROMs will be measured via the short form Hip disability and Osteoarthritis Outcome Score (HOOS-Jr). Surgeons can use a standard OR table vs. a specialized traction table (HANA) and may use fluoroscopy or no intraoperative imaging.
Interventions
PROCEDURETotal Hip Replacement with Automatic impaction and broaching device
Total hip replacement with the use of an automatic impaction and broaching device
PROCEDURETotal Hip Replacement
Total hip replacement without automatic impaction and broaching
Sponsors
Nova Scotia Health Authority
DePuy Synthes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients 70 years or older undergoing total hip replacement
Exclusion criteria
* Unable to undergo the informed consent process
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Periprosthetic fracture | 90 days | Intraoperative or early postoperative femoral/acetabular fractures in patients 70 years or older, when compared to traditional manual techniques in DA THA. * Measured via intraoperative reporting of fracture by surgeon (Yes/No), the postoperative CT scan by the radiologist (Yes/No) (CT scan performed within 1 week of operation) and by the radiograph at 3 months/90 days by the surgeon (Yes/No) * Outcome end point: 3 months/90 days (i.e. no fracture within 90 days of surgery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait analysis | 90 days | Preoperative and postoperative markerless motion capture at 3 months - gait speed, gait symmetry, cadence, step length, stance-time symmetry and hip flexion extension |
| Image based implant positioning | 7 days | Measured via femoral canal fill, femoral version, acetabular floor-cup gap on postoperative CT scan |
| Surgical efficiency | 1 day | Measured via operative time (minutes), broaching time (minutes), impaction time (minutes) |
| Surgical stress as measured by heart rate | 1 day | Measured via biometric assessment with wearable technology by the surgeon (Heart rate - beats per minute) |
| Surgical stress as measured by respiratory rate | 1 day | Measured via biometric assessment with wearable technology by the surgeon (respiratory rate - breaths/minute) |
| Patient reported outcome measure | 90 days | HOOS-JR (Hip Osteoarthritis Outcome Score - Joint Replacement). Scale is 0-100, with zero the worst possible hip problem and 100 being no hip problem. |
Countries
Canada
Contacts
CONTACTJhase Sniderman
Outcome results
None listed