Clinical trial NCT02499523: Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides
Official title: Prospective Randomised Controlled Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Materialise
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acetabular cup positioning
timeFrame: 2 Months post-operatively
Secondary outcomes:
measure: Surgery time
timeFrame: 1 day
measure: Acetabular cup size
timeFrame: 2 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: AZ Monica
Study officials:
affiliation: AZ Monica
name: Pieter Dolhain
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. Epub 2009 Jul 24.