NCT03846791

An Evaluation of Health Outcomes for Mako Hip Replacement

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Bournemouth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Hip

Interventions

Type	Name	Description
OTHER	Observational Study Post MAKO Robotic Surgery	To assess clinical outcomes and surgery related resource use in the year post surgery for patients undergoing hip replacement surgery using the MAKO robot

Timeline

• Start date: 2019-07-15
• Primary completion: 2024-05-03
• Completion: 2024-05-03
• First posted: 2019-02-20
• Last updated: 2024-08-13

Locations

2 sites across 1 country: United Kingdom