Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides

Materialise

Status: Terminated

Conditions: Osteoarthritis, Hip

Treatments: Procedure: THR with conventional technique; Procedure: THR with Acetabular Cup Orientation Guides (ACOG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02499523

SMAT003

Details and patient eligibility

About

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).

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7 participants in 2 patient groups

THR with conventional technique

Active Comparator group

Description:

Use of conventional technique in THR

Treatment:

Procedure: THR with conventional technique

THR with ACOG

Experimental group

Description:

THR with Acetabular Cup Orientation Guides (ACOG)

Treatment:

Procedure: THR with Acetabular Cup Orientation Guides (ACOG)