Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides

Materialise7 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis, Hip

Interventions

THR with conventional techniquePROCEDURE

THR with conventional technique.

THR with Acetabular Cup Orientation Guides (ACOG)PROCEDURE

THR with the ACOG System.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

AZ Monica

Antwerp, Belgium

Outcomes

Primary Outcomes

Acetabular cup positioning

Full leg computed tomography pre-operatively and post-operatively. Cup positioning will be recorded in both groups.

Time frame: 2 Months post-operatively

Secondary Outcomes

Surgery time

Time frame: 1 day

Acetabular cup size

Time frame: 2 months

Data from ClinicalTrials.gov

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