AzTrials
AzTrials

Arthropathy of HipNCT02884349

The Relationship Between Component Position and RoM

A study testing RoM assessment in people with Arthropathy of Hip, run by Golden Jubilee National Hospital at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Arthropathy of Hip
What is being tested?
RoM assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2016to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • Golden Jubilee National Hospital

    Clydebank, West Dunbartonshire, G81 4DY

    Kamal Deep, 0141 951 5392, kamal.deep@gjnh.scot.nhs.uk

    Alistair M Ewen, PhD, 0141 951 5946, alistair.ewen@gjnh.scot.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: An Investigation of the Relationship Between Total Hip Implant Position and Hip Range of Movement

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.

Read the 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.

Being tested
RoM assessment
Keywords
Computer aided orthopaedic surgery, Implant orientation, Range of motion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RoM assessmentProcedure or surgery

    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.

Study groups in NCT02884349
Study groupRoleWhat they receive
RoM assessmentExperimentalAll patients recruited to the study.
Receives: Procedure: RoM assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Actual hip range of movement in degrees measured using clinical movement analysis

    Hip RoM in three dimensions measured using clinical movement analysis techniques

    Measured: Three months

Secondary outcomes (14)
  1. Theoretical hip range of movement in degrees calculated from CT scans

    Hip RoM in three dimensions determined mathematically from the CT scan

    Measured: Three months

  2. 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

    Measured: Intra-operatively

  3. 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

    Measured: Three months

  4. Leg length discrepancy

    difference in leg length measured from the CT scan

    Measured: Three months

  5. Oxford Hip Score

    Patient reported hip pain and function

    Measured: Three months

  6. EQ-5D

    Patient reported quality of life

    Measured: Three months

  7. Harris Hip Score

    Clinician assessed hip pain and function

    Measured: Three months

  8. Patient satisfaction measured on a five point Likert scale

    Patient reported satisfaction with hip

    Measured: Three months

  9. Number of dislocations in cohort

    Post-operative dislocations

    Measured: Three months

  10. Number of revisions in cohort

    Revision rate

    Measured: Three months

  11. Number of infections in cohort

    Post-operative surgical site infections

    Measured: Three months

  12. Operative time in minutes

    Length of operation

    Measured: Intra-operative

  13. Blood loss volume

    Amount of blood lost

    Measured: Intra-operative

  14. Blood transfusion (Yes/No)

    Peri-operative blood transfusion data

    Measured: Intra-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02884349
Sponsor's protocol ID
Ortho 15-08
Status last verified
Jul 2019
First submitted
18 May 2016
Last updated
1 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing RoM assessment in people with Arthropathy of Hip, run by Golden Jubilee National Hospital at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alistair M Ewen, Ph.D. (+44 141 951 5966, alistair.ewen@gjnh.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Actual hip range of movement in degrees measured using clinical movement analysis (time frame: Three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in