Prospective Randomised Controlled Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Materialise
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Acetabular cup positioning
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Acetabular cup positioning
Time Frame: 2 Months post-operatively
Full leg computed tomography pre-operatively and post-operatively. Cup positioning will be recorded in both groups.
Secondary Outcomes
- Surgery time(1 day)
- Acetabular cup size(2 months)