Osteoarthritis, Hip
Conditions
Brief summary
A prospective, interventional, monocentric, controlled and randomized study will compare a conventional surgical technique to a surgical technique with the assistance of the Acetabular Cup Orientation Guide (ACOG, Materialise) System during total hip replacement (THR).
Detailed description
Background: The Acetabular Cup Orientation Guide(ACOG) System from MATERIALISE NV was developed and is intended to be used as a surgical instrument to assist in the positioning of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative computed tomography (CT) imaging scans. Use of ACOG is a relative new technique. ACOG, based on CT imaging data, fit directly into the patient's anatomy and enable primary total hip replacement . Data showing extra benefit of this technique compared to conventional THR technique are not widely available. Aim: To determine the safety of this new surgical technique compared to conventional THR. Methods: 30 participants will be randomized to 2 groups. One group will be operated for a THR with the conventional technique and the other group will be operated for a THR with the assistance of the ACOG System. CT imaging will be taken pre and post operatively to measure cup orientation.
Interventions
PROCEDURETHR with conventional technique
THR with conventional technique.
PROCEDURETHR with Acetabular Cup Orientation Guides (ACOG)
THR with the ACOG System.
Sponsors
Materialise
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is selected to undergo a primary THR * Informed consent
Exclusion criteria
* Is unable to undergo CT imaging of the full pelvis * Requires surgical treatment within less than 4 weeks of initiation * Is unable to undergo a THR through a anterolateral approach * Presents acute/chronic local or systemic infection * Is allergic to polyamide * Patient's BMI \> 35 * Patients with severe wear of the acetabular rim or other disorders that affect acetabular rim anatomy and bony landmark recognition.Patients exhibiting severe wear. * Has impaired decision-making capacity * Is a prisoner * Is pregnant * Has metal components that will result in scatter on the CT imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acetabular cup positioning | 2 Months post-operatively | Full leg computed tomography pre-operatively and post-operatively. Cup positioning will be recorded in both groups. |
Secondary
| Measure | Time frame |
|---|---|
| Surgery time | 1 day |
| Acetabular cup size | 2 months |
Countries
Belgium
Outcome results
None listed