The Relationship Between Component Position and RoM

NCT02884349 | Unknown

• 1 other identifier: Ortho 15-08
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine the influence of the combined anteversion of acetabular cup and the femoral stem used in total hip arthroplasty on the theoretical and actual range of motion of the hip in three dimensional space.

Conditions

Arthropathy of Hip

Keywords

Computer aided orthopaedic surgery; Implant orientation; Range of motion

Outcome Measures

Primary Outcomes (1)

• Actual hip range of movement in degrees measured using clinical movement analysis

  Hip RoM in three dimensions measured using clinical movement analysis techniques

  Three months

Secondary Outcomes (14)

• Theoretical hip range of movement in degrees calculated from CT scans

  Three months

• On-table hip range of movement in degrees as measured by the operative navigation computer

  Intra-operatively

• Combined anteversion in degrees of the acetabular cup and femoral stem system measured from CT scans

  Three months

• Leg length discrepancy

  Three months

• Oxford Hip Score

  Three months

Study Arms (1)

RoM assessment

EXPERIMENTAL

All patients recruited to the study.

Procedure: RoM assessment

Interventions

RoM assessment PROCEDURE

This group will have a CT scan at three months post-operatively instead of the two radiographs, an anterior/posterior pelvis view and a lateral hip view, which are standard care. They will also have a RoM assessment session in the movement analysis laboratory in the hospital at the same time point lasting about one hour, which is additional to standard care.

RoM assessment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total hip arthroplasty under the care of the participating consultant
• Males and females aged between 55 and 80 years
• Willing to return for the follow-up appointment
• Willing to take part
• Able to give informed consent

You may not qualify if:

• Revision total hip arthroplasty
• Second stage of staged bilateral total hip arthroplasty if already recruited for the first stage
• Males over 70 years (as per participating surgeon's standard practice for the Excia T stem)
• Females who are pregnant
• Not suitable to receive an Excia T stem, a Plasmacup or a ceramic head

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, G81 4DY, United Kingdom

RECRUITING

Study Officials

• Kamal Deep, M.D.

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alistair M Ewen, Ph.D.

CONTACT

+44 141 951 5966; alistair.ewen@gjnh.scot.nhs.uk

Hollie Leonard

CONTACT

+44 141 951 5533; hollie.leonard@gjnh.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: August 31, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)