Osteoarthritis, HipHELLONCT03846791
An Evaluation of Health Outcomes for Mako Hip Replacement
An observational study of Osteoarthritis, Hip, run by Bournemouth University at 2 sites in United Kingdom.
Trial summary
To assess clinical outcomes and surgery related resource use in the year post surgery for patients undergoing hip replacement using the Mako Robo Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Observational Study Post MAKO Robotic Surgery
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Jul 2019to 3 May 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing Robot Assisted Total Hip Replacement at the Nuffield Health
Who may be able to join
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, suitable for unilateral primary hip replacement;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Voluntary written Informed Consent obtained.
- Participant able to complete study follow-up.
Who cannot join
- Prospect for recovery to independent mobility compromised by known coexistent medical problems;
- Requiring revision hip replacement;
- Previous hip replacement (resurfacing or THR) on the contralateral side, with outcome achieving an Oxford Hip score <18 points;
- Likely post-operative leg length inequality >5cm;
- Neuromuscular disease affecting hip (Parkinson's, cerebral palsy, other spasticity);
- Primary or metastatic tumor involving this hip;
Show all 18Show fewer
- Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
- Previous arthrodesis or excision arthroplasty
- Acetabular deficiency - >2cm superior loss acetabular dome or >1.5cm protrusion acetabulae or wall deficiency> half a wall;
- Dysplasia (DDH) with >2.5cm subluxation or complete dislocation;
- Body mass index > 40kg/m2;
- Active or previous or suspected infection in this hip;
- Sepsis or osteomyelitis;
- Known sensitivity to device materials;
- Not physically able to use Grail gait lab and Primus muscle testing equipment;
- Women judged by the Investigator to be of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period;
- Unable to provide informed consent (insufficient English, cognitive disorder such as dementia, psychiatric illness);
- Unable to complete follow-ups (life expectancy <5 years, insufficient English, lives overseas, unable to return easily).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nuffield Health Bournemouth
Bournemouth, BH1 1RW
Orthopaedic Research Institute Bournemouth University
Bournemouth, BH8 8FT
About this study
To assess clinical outcomes and surgery related resource use in the year post surgery for patients undergoing hip replacement using the Mako Robo
Read the detailed description
This is an observational cohort study. It evaluates the recovery of 200 patients who are having routine robotic hip replacement surgery at a Nuffield Hospital in Bournemouth. Any complications from the surgery, or readmissions to hospital, will be reported. Investigators will measure how accurately the surgeon, assisted by the robotic-arm, positions the hip implant during the surgery using x-rays taken as part of routine care. The study also monitors the progress of rehabilitation by assessing pain and functional ability in the year following surgery, and will investigate whether there is an association between this recovery and a measurement of an area of muscle in the pelvic region, taken from a routine CT scan.
Patients will be asked to come to the Orthopaedic Research Institute at Bournemouth University to be assessed before they have surgery, and again at 3 weeks, 6-8 weeks, 3 months, 6 months and 12 months following surgery. At these visits they will be asked about their pain, how well they can do daily activities, and their quality of life. They will be assessed on their ability to sit-to-stand five times, walk for 40m, and climb some stairs. At each visit, except the three weeks visit, they will also have their gait tested on a specialised clinical treadmill, and the muscle strength in their legs measured. They will also be measured for oedema at baseline, 3 weeks and 6-8 weeks using a Fit3D ProScanner. These visits are in addition to the routine clinical follow-up visits at Nuffield Hospital. Participants will also be invited to wear a wrist activity monitor for at least three consecutive days prior to surgery and for the 6 weeks following discharge so that their activity can be recorded.
Surgery-related resource use of the procedure will also be reported, such as length of hospital stay, time in theatre, unplanned hospital visits, non-routine medication, outpatient appointments and physiotherapy appointments.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Observational Study Post MAKO Robotic Surgery
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Study Post MAKO Robotic SurgeryOther
To assess clinical outcomes and surgery related resource use in the year post surgery for patients undergoing hip replacement surgery using the MAKO robot
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of surgical complications post surgery
This study's primary outcome is to report on surgical complications. Events will be sub-classified as device (prosthesis or robot) or surgeon related.
Measured: 1 Year post surgery
The measurement of readmission post surgery
This study's primary outcome is to report on surgical complications. Events will be sub-classified as device (prosthesis or robot) or surgeon related.
Measured: 1 Year post surgery
Secondary outcomes (18)
Accuracy of component positioning
Placement of prosthetic components will be evaluated by assessing radiographs
Measured: 1 Year post surgery
Functional Assessments - Chair stand
30 s Chair Stand test as recommended by the Osteoarthritis Research Society International (OARSI). Assessment will be done prior to surgery, and again at 3 weeks, 6-8 weeks, 3 months, 6 months and 1 year following surgery
Measured: 1 Year post surgery
Functional Assessments - Fast paced Walk
40m fast-paced walk test as recommended by the Osteoarthritis Research Society International (OARSI). Assessment will be done prior to surgery, and again at 3 weeks, 6-8 weeks, 3 months, 6 months and 1 year following surgery
Measured: 1 Year post surgery
Functional Assessments - Stair Climb
Stair climb test as recommended by the Osteoarthritis Research Society International (OARSI). Assessment will be done prior to surgery, and again at 3 weeks, 6-8 weeks, 3 months, 6 months and 1 year following surgery
Measured: 1 Year post surgery
Gait analysis
Participants' gait will be analysed using the GRAIL MotekForce at baseline, 6-8 weeks, 3 months, 6 months and 1 year following surgery.
Measured: 1 Year post surgery
Muscle Testing
Participants' muscle strength will be analysed using the Primus BTE at baseline, 6-8 weeks, 3 months, 6 months and 1 year following surgery.
Measured: 1 Year post surgery
Measurement of pre-operative psoas muscle mass
This measurement will be taken from the pre-surgery CT scan
Measured: Pre-Operative
Patient Reported Outcome Measures - EQ-5D Quality of Life Score
EQ-5D Quality of Life Score will be assessed at pre-surgery and at 6 months.
Measured: 6 Months post surgery
Patient Reported Outcome Measures - The Pain Catastrophizing Score (PCS)
The Pain Catastrophizing Score (PCS) will be assessed prior to surgery.
Measured: Pre-Operative
Patient Reported Outcome Measures - The Hip Disability and Osteoarthritis Outcome Score (HOOS)
The Hip Disability and Osteoarthritis Outcome Score (HOOS) will be assessed at pre-surgery, 3 weeks, 6-8 weeks, 3 month, 6 months and 1 year following surgery
Measured: 1 Year post surgery
Surgery related resource use - length of stay in hospital
Data will be reported on surgery-related use of resources for length of stay in hospital
Measured: 1 Year post surgery
Surgery related resource use - time in theatre
Data will be reported on surgery-related use of resources for time in theatre
Measured: 1 Year post surgery
Surgery related resource use - unplanned hospital visits
Data will be reported on surgery-related use of resources for unplanned hospital visits
Measured: 1 Year post surgery
Surgery related resource use - non-routine medication
Data will be reported on surgery-related use of resources for non-routine medication
Measured: 1 Year post surgery
Surgery related resource use - number of outpatient appointments
Data will be reported on surgery-related use of resources for number of outpatient appointments
Measured: 1 Year post surgery
Surgery related resource use - number of physiotherapy appointments
Data will be reported on surgery-related use of resources for number of physiotherapy appointments.
Measured: 1 Year post surgery
Monitoring of physical activity
Participants will be invited to wear an activity monitor on their wrist for at least three consecutive days prior to surgery, and for the 6-8 weeks following discharge
Measured: 6-8 weeks following surgery
Measurement of oedema
Participants will be assessed for oedema using a Fit3D ProScanner at baseline, 3 weeks and 6-8 weeks following surgery.
Measured: 6-8 weeks following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start15 Jul 2019
- Primary completion3 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Nuffield Health Bournemouth, Orthopaedic Research Institute, Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Tom Wainwright, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846791
- Sponsor's protocol ID
- ORI/Mako/18
- Acronym
- HELLO
- Status last verified
- Aug 2024
- First submitted
- 13 Feb 2019
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Health Outcomes for Mako Hip Replacement
- ClinicalTrials.gov ID
- NCT03846791
- Acronym / sponsor ID
- HELLO / ORI/Mako/18
- Conditions
- Osteoarthritis, Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Nuffield Health Bournemouth, Orthopaedic Research Institute, Stryker Orthopaedics
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 20 Feb 2019 (actual)
- 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.
To assess clinical outcomes and surgery related resource use in the year post surgery for patients undergoing hip replacement using the Mako Robo
Detailed description
This is an observational cohort study. It evaluates the recovery of 200 patients who are having routine robotic hip replacement surgery at a Nuffield Hospital in Bournemouth. Any complications from the surgery, or readmissions to hospital, will be reported. Investigators will measure how accurately the surgeon, assisted by the robotic-arm, positions the hip implant during the surgery using x-rays taken as part of routine care. The study also monitors the progress of rehabilitation by assessing pain and functional ability in the year following surgery, and will investigate whether there is an association between this recovery and a measurement of an area of muscle in the pelvic region, taken from a routine CT scan.
Patients will be asked to come to the Orthopaedic Research Institute at Bournemouth University to be assessed before they have surgery, and again at 3 weeks, 6-8 weeks, 3 months, 6 months and 12 months following surgery. At these visits they will be asked about their pain, how well they can do daily activities, and their quality of life. They will be assessed on their ability to sit-to-stand five times, walk for 40m, and climb some stairs. At each visit, except the three weeks visit, they will also have their gait tested on a specialised clinical treadmill, and the muscle strength in their legs measured. They will also be measured for oedema at baseline, 3 weeks and 6-8 weeks using a Fit3D ProScanner. These visits are in addition to the routine clinical follow-up visits at Nuffield Hospital. Participants will also be invited to wear a wrist activity monitor for at least three consecutive days prior to surgery and for the 6 weeks following discharge so that their activity can be recorded.
Surgery-related resource use of the procedure will also be reported, such as length of hospital stay, time in theatre, unplanned hospital visits, non-routine medication, outpatient appointments and physiotherapy appointments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing Robot Assisted Total Hip Replacement at the Nuffield Health
Key inclusion criteria (5 listed)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, suitable for unilateral primary hip replacement;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Voluntary written Informed Consent obtained.
- Participant able to complete study follow-up.
Key exclusion criteria (18 listed)
- Prospect for recovery to independent mobility compromised by known coexistent medical problems;
- Requiring revision hip replacement;
- Previous hip replacement (resurfacing or THR) on the contralateral side, with outcome achieving an Oxford Hip score <18 points;
- Likely post-operative leg length inequality >5cm;
- Neuromuscular disease affecting hip (Parkinson's, cerebral palsy, other spasticity);
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 |
|---|---|---|
| Observational Study Post MAKO Robotic SurgeryTo assess clinical outcomes and surgery related resource use in the year post surgery for patients undergoing hip replacement surgery using the MAKO robot | Other | – |
Primary outcome
The measurement of surgical complications post surgery
Time frame: 1 Year post surgery
This study's primary outcome is to report on surgical complications. Events will be sub-classified as device (prosthesis or robot) or surgeon related.
The measurement of readmission post surgery
Time frame: 1 Year post surgery
This study's primary outcome is to report on surgical complications. Events will be sub-classified as device (prosthesis or robot) or surgeon related.
18 secondary outcomes
Accuracy of component positioning
Time frame: 1 Year post surgery
Functional Assessments - Chair stand
Time frame: 1 Year post surgery
Functional Assessments - Fast paced Walk
Time frame: 1 Year post surgery
Functional Assessments - Stair Climb
Time frame: 1 Year post surgery
Gait analysis
Time frame: 1 Year post surgery
Muscle Testing
Time frame: 1 Year post surgery
Measurement of pre-operative psoas muscle mass
Time frame: Pre-Operative
Patient Reported Outcome Measures - EQ-5D Quality of Life Score
Time frame: 6 Months post surgery
Patient Reported Outcome Measures - The Pain Catastrophizing Score (PCS)
Time frame: Pre-Operative
Patient Reported Outcome Measures - The Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time frame: 1 Year post surgery
Surgery related resource use - length of stay in hospital
Time frame: 1 Year post surgery
Surgery related resource use - time in theatre
Time frame: 1 Year post surgery
Surgery related resource use - unplanned hospital visits
Time frame: 1 Year post surgery
Surgery related resource use - non-routine medication
Time frame: 1 Year post surgery
Surgery related resource use - number of outpatient appointments
Time frame: 1 Year post surgery
Surgery related resource use - number of physiotherapy appointments
Time frame: 1 Year post surgery
Monitoring of physical activity
Time frame: 6-8 weeks following surgery
Measurement of oedema
Time frame: 6-8 weeks following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Hip
Active, not recruiting
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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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.
Tom Wainwright study director
Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip, run by Bournemouth University at 2 sites 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 18 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: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurement of surgical complications post surgery (time frame: 1 Year post surgery). The study lists 2 primary outcomes in all. 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 13 Aug 2024.