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.
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
- 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
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.
- Conditions
- Arthropathy of Hip
- 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 group | Role | What they receive |
|---|---|---|
| RoM assessment | Experimental | All 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.
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)
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
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
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
Leg length discrepancy
difference in leg length measured from the CT scan
Measured: Three months
Oxford Hip Score
Patient reported hip pain and function
Measured: Three months
EQ-5D
Patient reported quality of life
Measured: Three months
Harris Hip Score
Clinician assessed hip pain and function
Measured: Three months
Patient satisfaction measured on a five point Likert scale
Patient reported satisfaction with hip
Measured: Three months
Number of dislocations in cohort
Post-operative dislocations
Measured: Three months
Number of revisions in cohort
Revision rate
Measured: Three months
Number of infections in cohort
Post-operative surgical site infections
Measured: Three months
Operative time in minutes
Length of operation
Measured: Intra-operative
Blood loss volume
Amount of blood lost
Measured: Intra-operative
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.
- First posted31 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kamal Deep, M.D., Principal investigator, Golden Jubilee National Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Relationship Between Total Hip Implant Position and Hip Range of Movement
- ClinicalTrials.gov ID
- NCT02884349
- Acronym / sponsor ID
- Ortho 15-08
- Conditions
- Arthropathy of Hip
- Keywords
- Computer aided orthopaedic surgery, Implant orientation, Range of motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RoM assessment | Experimental | Procedure: RoM assessmentAll patients recruited to the study. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoM assessmentThis 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. | Procedure or surgery | RoM assessment |
Primary outcome
Actual hip range of movement in degrees measured using clinical movement analysis
Time frame: Three months
Hip RoM in three dimensions measured using clinical movement analysis techniques
14 secondary outcomes
Theoretical hip range of movement in degrees calculated from CT scans
Time frame: Three months
On-table hip range of movement in degrees as measured by the operative navigation computer
Time frame: Intra-operatively
Combined anteversion in degrees of the acetabular cup and femoral stem system measured from CT scans
Time frame: Three months
Leg length discrepancy
Time frame: Three months
Oxford Hip Score
Time frame: Three months
EQ-5D
Time frame: Three months
Harris Hip Score
Time frame: Three months
Patient satisfaction measured on a five point Likert scale
Time frame: Three months
Number of dislocations in cohort
Time frame: Three months
Number of revisions in cohort
Time frame: Three months
Number of infections in cohort
Time frame: Three months
Operative time in minutes
Time frame: Intra-operative
Blood loss volume
Time frame: Intra-operative
Blood transfusion (Yes/No)
Time frame: Intra-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal Deep, M.D. principal investigator
Golden Jubilee National Hospital
1 site in 1 country: see every site and its status.
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.