Study Stopped
Low recruitment rate
Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides
Prospective Randomised Controlled Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides
1 other identifier
interventional
7
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 16, 2014
CompletedFirst Submitted
Initial submission to the registry
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2016
CompletedMarch 28, 2017
March 1, 2017
2.4 years
July 1, 2015
March 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Surgery time
1 day
Acetabular cup size
2 months
Study Arms (2)
THR with conventional technique
ACTIVE COMPARATORUse of conventional technique in THR
THR with ACOG
EXPERIMENTALTHR with Acetabular Cup Orientation Guides (ACOG)
Interventions
THR with conventional technique.
THR with the ACOG System.
Eligibility Criteria
You may qualify if:
- Is selected to undergo a primary THR
- Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Materialiselead
Study Sites (1)
AZ Monica
Antwerp, 2018, Belgium
Related 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.
PMID: 19248055RESULTHananouchi 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.
PMID: 19629605RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pieter Dolhain
AZ Monica
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2015
First Posted
July 16, 2015
Study Start
June 16, 2014
Primary Completion
October 21, 2016
Study Completion
October 21, 2016
Last Updated
March 28, 2017
Record last verified: 2017-03