Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides

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

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).

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Procedure: THR with conventional technique; Procedure: THR with Acetabular Cup Orientation Guides (ACOG)

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2018
    • AZ Monica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: THR with conventional technique; Use of conventional technique in THR	Procedure: THR with conventional technique; THR with conventional technique.
Experimental: THR with ACOG; THR with Acetabular Cup Orientation Guides (ACOG)	Procedure: THR with Acetabular Cup Orientation Guides (ACOG); THR with the ACOG System.; Other Names: ACOG, Materialise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acetabular cup positioning	Full leg computed tomography pre-operatively and post-operatively. Cup positioning will be recorded in both groups.	2 Months post-operatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgery time	1 day
Acetabular cup size	2 months

Collaborators and Investigators

• Sponsor: Materialise
• Investigators: Principal Investigator: Pieter Dolhain, AZ Monica

Publications and helpful links

General Publications

• Hananouchi T, Saito M, Koyama T, Hagio K, Murase T, Sugano N, Yoshikawa H. Tailor-made surgical guide based on rapid prototyping technique for cup insertion in total hip arthroplasty. Int J Med Robot. 2009 Jun;5(2):164-9. doi: 10.1002/rcs.243.
• Hananouchi T, Saito M, Koyama T, Sugano N, Yoshikawa H. Tailor-made Surgical Guide Reduces Incidence of Outliers of Cup Placement. Clin Orthop Relat Res. 2010 Apr;468(4):1088-95. doi: 10.1007/s11999-009-0994-4. Epub 2009 Jul 24.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2014
• Primary Completion (Actual): October 21, 2016
• Study Completion (Actual): October 21, 2016

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: SMAT003