Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| UCLA Health - Santa Monica Medical Center | UNKNOWN |
| University of Virginia | OTHER |
| Orthopedic + Fracture Specialists, Portland, OR | OTHER |
Not provided
Not provided
Not provided
This study investigates the use of an automated impactor device in total hip arthroplasty versus manual malleting method and the physiological strain on the surgeon. This study will be a randomized, prospective, multicenter study involving fellowship-trained arthroplasty surgeons. Each participating surgeon will contribute data from 50 primary, elective THA cases, using the HAMMR powered impactor in 25 cases and manual impaction in 25 cases.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Malleting Group | Active Comparator | For cases that are randomized to the manual malleting group, surgeons will utilize a manual mallet to perform impaction during total hip arthroplasty while wearing the Hexoskin shirt. |
|
| Automated Impaction HAMMR Group | Active Comparator | For cases that are randomized to the automated impaction HAMMR group, surgeons will utilize an automated impaction device to perform impaction during total hip arthroplasty while wearing the Hexoskin shirt. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated Impaction (HAMMR) | Device | For cases that are randomized to the automated impaction HAMMR group, the surgeon will utilize an automated impactor device for impaction of the implant during total hip arthroplasty. |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological strain in the surgeon | Through the use of a Hexoskin vest worn by the surgeon, we will measure heart rate, heart rate variability, respiratory rate, minute ventilation, and energy expenditure to determine overall physiological strain on the surgeon during total hip arthroplasty. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Adverse Events | Patient adverse events such as periprosthetic fractures intra- or postoperatively, intraoperative soft tissue injury, etc. will be recorded intra or postoperatively. | 6 weeks |
| F-NRS |
Not provided
Inclusion Criteria:
Patients undergoing primary elective THAs Participants over the age of 18 Patients with compatible implants
Exclusion Criteria:
Attending orthopaedic surgeons with pre-existing cardiorespiratory or musculoskeletal conditions Use of cemented or hybrid THA Patients undergoing a conversion or revision THA Patients undergoing a non-elective THA (i.e., for fracture) Participants lacking cognitive capacity to consent Participants who are pregnant
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Camilo Restrepo, MD | Rothman Orthopaedic Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Manual Malleting | Device | For cases that are randomized to the manual malleting group, the surgeon will utilize a mallet for impaction of the implant during total hip arthroplasty. |
|
We will assess the Fatigue numeric rating scale (F-NRS) of surgeons after each case via survey.
| 1 day |