An interventional study of Automated Impaction (HAMMR) and Manual Malleting in Total Hip Arthroplasty (THA), Impaction and Physiological Strain, sponsored by Rothman Institute Orthopaedics. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Rothman Institute Orthopaedics · Not applicable, Interventional, and Diagnostic
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.
246 studies on the registry are indexed under Sprains and Strains; 49 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 162 interventional studies indexed under Sprains and Strains.
Browse Sprains and Strains studies →Rothman Institute Orthopaedics is the lead sponsor of 119 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
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.
Device: Manual Malleting
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.
Device: Automated Impaction (HAMMR)
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.
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.
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.
Time frame: 1 day
Patient Adverse Events
Patient adverse events such as periprosthetic fractures intra- or postoperatively, intraoperative soft tissue injury, etc. will be recorded intra or postoperatively.
Time frame: 6 weeks
F-NRS
We will assess the Fatigue numeric rating scale (F-NRS) of surgeons after each case via survey.
Time frame: 1 day
Started Mar 2025 (actual). Primary completion is estimated for Mar 2026, 12 months after the start.
Of 80 non-industry interventional studies with no phase under Sprains and Strains, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 35. This study's planned 12 months is close to that.
Counting every sponsor, half of 82 studies reached it within 12 months; a quarter within 4 and three quarters within 35.
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