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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03560063
Other study ID # IRAS 216084
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date May 2022

Study information

Verified date May 2018
Source University of Oxford
Contact Marian Montgomery
Phone +44 1865 737262
Email hapi@ndorms.ox.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to determine whether the Corin Optimised Positioning System (Corin, U.K.) reduces the rate of hip dislocation at one-year post-operatively compared with standard templating in patients undergoing total hip replacement.

The secondary objectives of this study are to determine whether the Corin Optimised Positioning System (Corin, U.K.) improves functional outcomes, reduces length of hospital stay, and reduces leg length discrepancy compared with standard templating in patients undergoing total hip replacement.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Corin Optimised Positioning System
Total hip replacement with implant positioning guided by Corin Optimised Positioning System. The experimental and active comparator arms will use the same implants for total hip replacements. The Corin Trinity shell system will be used for the acetabular system. The Corin MiniHip, TriFit, MetaFix and TaperFit implants will be used for the femoral stem implant. Surgeons will select the implant most appropriate for each patient.
Standard templating
Total hip replacement with implant positioning guided by standard templating. The experimental and active comparator arms will use the same implants for total hip replacements. The Corin Trinity shell system will be used for the acetabular system. The Corin MiniHip, TriFit, MetaFix and TaperFit implants will be used for the femoral stem implant. Surgeons will select the implant most appropriate for each patient.

Locations

Country Name City State
United Kingdom Nuffield Orthopaedic Centre, Oxford University Hospitals Trust Oxford

Sponsors (3)

Lead Sponsor Collaborator
University of Oxford Corin, Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dislocation rate Incidence of hip dislocation within 12 months post-operatively 12 months
Secondary Change in Harris Hip Score A clinician recorded outcome score to assess functional improvement. Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Secondary Change in Oxford Hip Score A patient reported outcome measure (PROM) to assess patient benefit Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Secondary Change in Hip and Groin Outcome Score A PROM to assess patient benefit Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Secondary Change in International Hip Outcome Tool 33 (iHOT33) Score A PROM to assess patient benefit Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Secondary Change in EuroQol 5 dimension (EQ5D) Score A PROM to assess patient benefit Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Secondary Change in University of California, Los Angeles (UCLA) Activity Score A PROM to assess patient benefit Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Secondary Change in Forgotten Joint Score A PROM to assess patient benefit Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Secondary Length of hospital stay Measurement of the length of the hospital admission for the total hip replacement. Measured in days. Through study completion, an average of 1 year
Secondary Operation duration Measurement of the length of time of the total hip replacement operation. Measured in minutes. Through study completion, an average of 1 year
Secondary Discrepancy in leg length Assessment for correction in discrepancy in true leg length from pre-operative to post-operative. Measured in cm Measured pre-operatively and at 12 months post-operatively
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