Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides

Not Applicable

Terminated

• Conditions: Osteoarthritis, Hip
• Interventions: Procedure: THR with conventional technique; Procedure: THR with Acetabular Cup Orientation Guides (ACOG)

• 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

Arm && Interventions

Group	Intervention	Description
THR with conventional technique	THR with conventional technique	Use of conventional technique in THR
THR with ACOG	THR with Acetabular Cup Orientation Guides (ACOG)	THR with Acetabular Cup Orientation Guides (ACOG)

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