Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomised Controlled Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Procedure: THR with conventional technique
* Procedure: THR with Acetabular Cup Orientation Guides (ACOG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: THR with conventional technique<br>Use of conventional technique in THR | Procedure: THR with conventional technique<br>* THR with conventional technique.<br>|
| Experimental: THR with ACOG<br>THR with Acetabular Cup Orientation Guides (ACOG) | Procedure: THR with Acetabular Cup Orientation Guides (ACOG)<br>* THR with the ACOG System.<br>* Other names: ACOG, Materialise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetabular cup positioning | Full leg computed tomography pre-operatively and post-operatively. Cup positioning will be recorded in both groups. | 2 Months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery time |  | 1 day | 
| Acetabular cup size |  | 2 months |