Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides

Not Applicable

Terminated

• Conditions: Osteoarthritis, Hip

• Registration Number: NCT02499523
• Lead Sponsor: Materialise

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.

Study Timeline

• Study Start: 2014-06-16
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Primary Completion: 2016-10-21
• Study Completion: 2016-10-21
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Surgery time	1 day
Acetabular cup size	2 months

Trial Locations

Locations (1)

AZ Monica; 🇧🇪 Antwerpen, Belgium