Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides
NCT ID: NCT02499523
Last Updated: 2017-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2014-06-16
2016-10-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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THR with conventional technique
Use of conventional technique in THR
THR with conventional technique
THR with conventional technique.
THR with ACOG
THR with Acetabular Cup Orientation Guides (ACOG)
THR with Acetabular Cup Orientation Guides (ACOG)
THR with the ACOG System.
Interventions
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THR with conventional technique
THR with conventional technique.
THR with Acetabular Cup Orientation Guides (ACOG)
THR with the ACOG System.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Materialise
INDUSTRY
Responsible Party
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Principal Investigators
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Pieter Dolhain
Role: PRINCIPAL_INVESTIGATOR
AZ Monica
Locations
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AZ Monica
Antwerp, , Belgium
Countries
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References
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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.
Other Identifiers
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SMAT003
Identifier Type: -
Identifier Source: org_study_id
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