Clinical trial NCT03846791: An Evaluation of Health Outcomes for Mako Hip Replacement
Official title: An Evaluation of Health Outcomes for Mako Hip Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Lead sponsor: Bournemouth University
Sponsor class: OTHER
Collaborators: name: Nuffield Health Bournemouth
name: Orthopaedic Research Institute
name: Stryker Orthopaedics
First posted: 2019-02-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Robot Assisted Total Hip Replacement at the Nuffield Health

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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).

Primary outcomes:
measure: The measurement of surgical complications post surgery
timeFrame: 1 Year post surgery
measure: The measurement of readmission post surgery
timeFrame: 1 Year post surgery
Secondary outcomes:
measure: Accuracy of component positioning
timeFrame: 1 Year post surgery
measure: Functional Assessments - Chair stand
timeFrame: 1 Year post surgery
measure: Functional Assessments - Fast paced Walk
timeFrame: 1 Year post surgery
measure: Functional Assessments - Stair Climb
timeFrame: 1 Year post surgery
measure: Gait analysis
timeFrame: 1 Year post surgery
measure: Muscle Testing
timeFrame: 1 Year post surgery
measure: Measurement of pre-operative psoas muscle mass
timeFrame: Pre-Operative
measure: Patient Reported Outcome Measures - EQ-5D Quality of Life Score
timeFrame: 6 Months post surgery
measure: Patient Reported Outcome Measures - The Pain Catastrophizing Score (PCS)
timeFrame: Pre-Operative
measure: Patient Reported Outcome Measures - The Hip Disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: 1 Year post surgery
measure: Surgery related resource use - length of stay in hospital
timeFrame: 1 Year post surgery
measure: Surgery related resource use - time in theatre
timeFrame: 1 Year post surgery
measure: Surgery related resource use - unplanned hospital visits
timeFrame: 1 Year post surgery
measure: Surgery related resource use - non-routine medication
timeFrame: 1 Year post surgery
measure: Surgery related resource use - number of outpatient appointments
timeFrame: 1 Year post surgery
measure: Surgery related resource use - number of physiotherapy appointments
timeFrame: 1 Year post surgery
measure: Monitoring of physical activity
timeFrame: 6-8 weeks following surgery
measure: Measurement of oedema
timeFrame: 6-8 weeks following surgery
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Nuffield Health Bournemouth
city: Bournemouth
country: United Kingdom
facility: Orthopaedic Research Institute Bournemouth University
Study officials:
affiliation: Professor
name: Tom Wainwright
role: STUDY_DIRECTOR
References: