Two Year Study With Robotic-Arm Assisted Hip Surgery.

West Virginia University

Status: Completed

Conditions: Hip Osteoarthritis; Surgery

Treatments: Procedure: Robotic-Arm Assisted THA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03891199

1808218345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control

No Intervention group

Description:

Traditional THA.

Intervention

Active Comparator group

Description:

Robotic-arm assisted THA.

Treatment:

Procedure: Robotic-Arm Assisted THA