An observational study in Osteoarthritis, Hip, sponsored by Bournemouth University. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Bournemouth University · Observational
To assess clinical outcomes and surgery related resource use in the year post surgery for patients undergoing hip replacement using the Mako Robo
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.
628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.
This study's enrollment of 200 is above the median of 141 across 154 observational studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Bournemouth University is the lead sponsor of 52 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing Robot Assisted Total Hip Replacement at the Nuffield Health
Exclusion Criteria:
To assess clinical outcomes and surgery related resource use in the year post surgery for patients undergoing hip replacement surgery using the MAKO robot
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.
Time frame: 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.
Time frame: 1 Year post surgery
Accuracy of component positioning
Placement of prosthetic components will be evaluated by assessing radiographs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 1 Year post surgery
Measurement of pre-operative psoas muscle mass
This measurement will be taken from the pre-surgery CT scan
Time frame: 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.
Time frame: 6 Months post surgery
Patient Reported Outcome Measures - The Pain Catastrophizing Score (PCS)
The Pain Catastrophizing Score (PCS) will be assessed prior to surgery.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 6-8 weeks following surgery
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Bournemouth University