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The Relationship Between Component Position and RoM

Primary Purpose

Arthropathy of Hip

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
RoM assessment
Sponsored by
Golden Jubilee National Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Arthropathy of Hip focused on measuring Computer aided orthopaedic surgery, Implant orientation, Range of motion

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Golden Jubilee National HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RoM assessment

Arm Description

All patients recruited to the study.

Outcomes

Primary Outcome Measures

Actual hip range of movement in degrees measured using clinical movement analysis
Hip RoM in three dimensions measured using clinical movement analysis techniques

Secondary Outcome Measures

Theoretical hip range of movement in degrees calculated from CT scans
Hip RoM in three dimensions determined mathematically from the CT scan
On-table hip range of movement in degrees as measured by the operative navigation computer
Hip RoM in three dimensions measured using the CAOS computer system
Combined anteversion in degrees of the acetabular cup and femoral stem system measured from CT scans
A measure of the hip implant orientation using the torsion of the stem and the version of the cup
Leg length discrepancy
difference in leg length measured from the CT scan
Oxford Hip Score
Patient reported hip pain and function
EQ-5D
Patient reported quality of life
Harris Hip Score
Clinician assessed hip pain and function
Patient satisfaction measured on a five point Likert scale
Patient reported satisfaction with hip
Number of dislocations in cohort
Post-operative dislocations
Number of revisions in cohort
Revision rate
Number of infections in cohort
Post-operative surgical site infections
Operative time in minutes
Length of operation
Blood loss volume
Amount of blood lost
Blood transfusion (Yes/No)
Peri-operative blood transfusion data

Full Information

First Posted
May 18, 2016
Last Updated
July 30, 2019
Sponsor
Golden Jubilee National Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02884349
Brief Title
The Relationship Between Component Position and RoM
Official Title
An Investigation of the Relationship Between Total Hip Implant Position and Hip Range of Movement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Golden Jubilee National Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Ninety patients from the clinics of a single consultant orthopaedic surgeon, who are listed to for total hip arthroplasty will be recruited to the study. They will have their surgery performed by the participating consultant as per his standard practice for the target study patient. This involves using the Excia T cementless stem, the ceramic femoral head, the Plasmafit Plus cementless liner and the Biolox delta acetabular cup all by B Braun Medical Ltd. The participating consultant routinely uses computer aided orthopaedic surgery (CAOS) techniques to implant the stem and the acetabular cup and all study patients will have surgery using these techniques. Participants will have their standard in-patient care and rehabilitation. Standard hospital practice for hip arthroplasty patients is for them to return to the hospital for a post-operative review at three months. During this appointment they will be reviewed by a member of the arthroplasty team and have two radiographs taken, an anterior/posterior view of the full pelvis and a lateral view of the index hip. Study participants will return for the three month post-operative review and be seen by the arthroplasty team as standard, but will not have the two radiographs taken. Instead, they will have a computed tomography (CT) scan taken of the full pelvis. In addition to the standard clinical outcome data collected, Participants will also complete the Harris Hip Score and a range of motion questionnaire. Study participants will also have an additional assessment as part of their three month post-operative review. In the movement analysis laboratory in the Golden Jubilee National Hospital, they will undergo a RoM assessment using clinical movement analysis techniques. During this assessment, participants will be asked to fully flex/extend their hip joint, fully abduct/adduct it, fully internally/externally rotate it and finally fully circumduct it. While performing these tasks, their hip joint movement will be tracked by a number of infrared cameras identifying small reflective markers attached to their body. A computer can convert these data into three dimensional RoM data for further analysis. At the end of their three month post-operative review, the participant's involvement in the study will be complete. The computer used for CAOS is capable of measuring the on-table range of motion (RoM) of the hip. This data will be collected for the purposes of the study. Mathematical methods will be used to determine the theoretical RoM of the hip from the CT scan. The data from the movement analysis session will give the actual RoM. The CT scan will be analysed to determine the inclination and version of the acetabular cup and the torsion of the femoral stem. From this, the combined anteversion (CA) of the cup/stem system will be determined. Comparison will be made between the CA and the actual RoM to determine to what extent, if any, the CA influences the RoM. Comparisons will be made between the on-table RoM and the theoretical RoM, and the actual RoM to assess the accuracy of the methods used to determine the on-table and theoretical RoMs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Hip
Keywords
Computer aided orthopaedic surgery, Implant orientation, Range of motion

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RoM assessment
Arm Type
Experimental
Arm Description
All patients recruited to the study.
Intervention Type
Procedure
Intervention Name(s)
RoM assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Actual hip range of movement in degrees measured using clinical movement analysis
Description
Hip RoM in three dimensions measured using clinical movement analysis techniques
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Theoretical hip range of movement in degrees calculated from CT scans
Description
Hip RoM in three dimensions determined mathematically from the CT scan
Time Frame
Three months
Title
On-table hip range of movement in degrees as measured by the operative navigation computer
Description
Hip RoM in three dimensions measured using the CAOS computer system
Time Frame
Intra-operatively
Title
Combined anteversion in degrees of the acetabular cup and femoral stem system measured from CT scans
Description
A measure of the hip implant orientation using the torsion of the stem and the version of the cup
Time Frame
Three months
Title
Leg length discrepancy
Description
difference in leg length measured from the CT scan
Time Frame
Three months
Title
Oxford Hip Score
Description
Patient reported hip pain and function
Time Frame
Three months
Title
EQ-5D
Description
Patient reported quality of life
Time Frame
Three months
Title
Harris Hip Score
Description
Clinician assessed hip pain and function
Time Frame
Three months
Title
Patient satisfaction measured on a five point Likert scale
Description
Patient reported satisfaction with hip
Time Frame
Three months
Title
Number of dislocations in cohort
Description
Post-operative dislocations
Time Frame
Three months
Title
Number of revisions in cohort
Description
Revision rate
Time Frame
Three months
Title
Number of infections in cohort
Description
Post-operative surgical site infections
Time Frame
Three months
Title
Operative time in minutes
Description
Length of operation
Time Frame
Intra-operative
Title
Blood loss volume
Description
Amount of blood lost
Time Frame
Intra-operative
Title
Blood transfusion (Yes/No)
Description
Peri-operative blood transfusion data
Time Frame
Intra-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alistair M Ewen, Ph.D.
Phone
+44 141 951 5966
Email
alistair.ewen@gjnh.scot.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Hollie Leonard
Phone
+44 141 951 5533
Email
hollie.leonard@gjnh.scot.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamal Deep, M.D.
Organizational Affiliation
Golden Jubilee National Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Golden Jubilee National Hospital
City
Clydebank
State/Province
West Dunbartonshire
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamal Deep
Phone
0141 951 5392
Email
kamal.deep@gjnh.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Alistair M Ewen, PhD
Phone
0141 951 5946
Email
alistair.ewen@gjnh.scot.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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The Relationship Between Component Position and RoM

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