Trial Outcomes & Findings for Evaluation of X-ray, Acetabular Guides and CT in THR (NCT NCT03072706)
NCT ID: NCT03072706
Last Updated: 2026-02-24
Results Overview
The difference between planned and achieved acetabular cup anteversion assessed by post-operative CT scan
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
6 weeks (+/- 2 weeks) post-surgery
Results posted on
2026-02-24
Participant Flow
Participant milestones
| Measure |
Standard Group
2D X-ray templating technology
2D X-ray templating technology: Standard care where hip replacement is planned using 2D X-ray templating software
|
Corin OPS™
Corin Optimised Positioning System (OPS) Dynamic Hip Analysis
Corin OPS™: The OPS Dynamic Hip Analysis is a computer software package used to generate simulations of a total joint replacement from patient imaging. The dynamic simulation is used for operative planning, including implant selection, sizing and placement; and to create custom instruments or delivery specifications referencing the patient's anatomy and bio-mechanics. The simulation can also be used for the post-operative evaluation of joint performance.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of X-ray, Acetabular Guides and CT in THR
Baseline characteristics by cohort
| Measure |
Standard Group
n=27 Participants
2D X-ray templating technology
2D X-ray templating technology: Standard care where hip replacement is planned using 2D X-ray templating software
|
Corin OPS™
n=27 Participants
Corin Optimised Positioning System (OPS) Dynamic Hip Analysis
Corin OPS™: The OPS Dynamic Hip Analysis is a computer software package used to generate simulations of a total joint replacement from patient imaging. The dynamic simulation is used for operative planning, including implant selection, sizing and placement; and to create custom instruments or delivery specifications referencing the patient's anatomy and bio-mechanics. The simulation can also be used for the post-operative evaluation of joint performance.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 9.8 • n=58 Participants
|
58.8 years
STANDARD_DEVIATION 7.4
|
58.1 years
STANDARD_DEVIATION 8.6 • n=1 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=58 Participants
|
18 Participants
|
30 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=58 Participants
|
9 Participants
|
24 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=58 Participants
|
23 Participants
|
47 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=58 Participants
|
4 Participants
|
7 Participants
n=1 Participants
|
|
Region of Enrollment
United Kingdom
|
27 participants
n=58 Participants
|
27 participants
|
54 participants
n=1 Participants
|
|
BMI
|
29.7 kg/m2
STANDARD_DEVIATION 5.0 • n=58 Participants
|
30.3 kg/m2
STANDARD_DEVIATION 4.8
|
30.0 kg/m2
STANDARD_DEVIATION 4.9 • n=1 Participants
|
PRIMARY outcome
Timeframe: 6 weeks (+/- 2 weeks) post-surgeryThe difference between planned and achieved acetabular cup anteversion assessed by post-operative CT scan
Outcome measures
| Measure |
Standard Group
n=27 Participants
2D X-ray templating technology
2D X-ray templating technology: Standard care where hip replacement is planned using 2D X-ray templating software
|
Corin OPS™
n=27 Participants
Corin Optimised Positioning System (OPS) Dynamic Hip Analysis
Corin OPS™: The OPS Dynamic Hip Analysis is a computer software package used to generate simulations of a total joint replacement from patient imaging. The dynamic simulation is used for operative planning, including implant selection, sizing and placement; and to create custom instruments or delivery specifications referencing the patient's anatomy and bio-mechanics. The simulation can also be used for the post-operative evaluation of joint performance.
|
|---|---|---|
|
Acetabular Cup Anteversion Angle
|
5.8 degree
Standard Deviation 5.8
|
3.7 degree
Standard Deviation 2.9
|
Adverse Events
Standard Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Corin OPS™
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Group
n=27 participants at risk
2D X-ray templating technology
2D X-ray templating technology: Standard care where hip replacement is planned using 2D X-ray templating software
|
Corin OPS™
n=27 participants at risk
Corin Optimised Positioning System (OPS) Dynamic Hip Analysis
Corin OPS™: The OPS Dynamic Hip Analysis is a computer software package used to generate simulations of a total joint replacement from patient imaging. The dynamic simulation is used for operative planning, including implant selection, sizing and placement; and to create custom instruments or delivery specifications referencing the patient's anatomy and bio-mechanics. The simulation can also be used for the post-operative evaluation of joint performance.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/27 • From consent to the last follow-up visit at 12 months.
|
3.7%
1/27 • Number of events 2 • From consent to the last follow-up visit at 12 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Professor Richard King
University Hospitals Coventry and Warwickshire NHS Trust
Phone: 02476 965065
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place