Clinical trial NCT03891199: Two Year Study With Robotic-Arm Assisted Hip Surgery.
Official title: A Two Year Multicenter Study of Robotic-Arm Assisted THA: Acetabular Cup Placement Accuracy and Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Hip Osteoarthritis
Keywords: clinical trial
randomization
hip arthroplasty
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
name: West Penn Allegheny Health System
First posted: 2019-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers. Specifically looking at acetabular cup placement during Total Hip Arthroplasty by either traditional or robotic-arm assisted placement.

Detailed description: The incidence of dislocation following total hip arthroplasty (THA) has been reported to be from 1% to as much as 3.2%. The demand for THA is expected to increase. Post- dislocation solutions include closed reduction, open reduction, THA revision, and constrained cup, conversion to hemiarthroplasty, allograft or girdlestone resection. These solutions are often costly, painful and can involve substantial additional risks and complications. Acetabular cup placement is an important factor in the stability of the THA. Cup malpositioning has been associated with bearing surface ware and dislocation. For most patients, acceptable angles for abduction are 40° abduction (±10°) and 20° (±5°) version. However, malpositioning continues to occur resulting in cup angles outside acceptable ranges and leaving patients with an increased risk of dislocation.

This objective of this study is to examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.

Eligibility criteria: Inclusion Criteria:

1. Patients requiring primary total hip arthroplasty
2. Patients willing and able to comply with follow-up requirements
3. Patients willing to sign an Institutional Review Board approved informed consent form.

Exclusion Criteria:

1. Patients with Body Mass Index \>45
2. Patients who are \<18 years of age
3. Patients with an active infection or suspected latent infection in or about the hip joint
4. Bone stock that is inadequate for support or fixation of the prosthesis
5. Previous major hip surgery excluding hip arthroscopy
6. Total hip arthroplasty using cement fixation or resurfacing

Primary outcomes:
measure: Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version.
timeFrame: 6 months
measure: Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period.
timeFrame: 1 Year
measure: Change in "Patient-Reported Outcomes Measurement Information System" (PROMIS) Survey Over a 1 Year Period.
timeFrame: 1year
measure: Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination.
timeFrame: 6 months
measure: Adherence to Lewinnek Safe Zone
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: WVU Medicine
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Matthew J Dietz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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