Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02499523
• Other study ID #: SMAT003
• Status: Terminated
• Phase: N/A
• First received: July 1, 2015
• Last updated: March 24, 2017
• Start date: June 16, 2014
• Est. completion date: October 21, 2016

Study information

• Verified date: March 2017
• Source: Materialise
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 21, 2016
• Est. primary completion date: October 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• THR with conventional technique
THR with conventional technique.
• THR with Acetabular Cup Orientation Guides (ACOG)
THR with the ACOG System.

Locations

Country	Name	City	State
Belgium	AZ Monica	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Materialise

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgery time		1 day
Secondary	Acetabular cup size		2 months