NCT02499523

Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Materialise · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Hip

Interventions

Type	Name	Description
PROCEDURE	THR with conventional technique	THR with conventional technique.
PROCEDURE	THR with Acetabular Cup Orientation Guides (ACOG)	THR with the ACOG System.

Timeline

• Start date: 2014-06-16
• Primary completion: 2016-10-21
• Completion: 2016-10-21
• First posted: 2015-07-16
• Last updated: 2017-03-28

Locations

1 site across 1 country: Belgium