Status:
COMPLETED
An Evaluation of Health Outcomes for Mako Hip Replacement
Lead Sponsor:
Bournemouth University
Collaborating Sponsors:
Nuffield Health Bournemouth
Orthopaedic Research Institute
Conditions:
Osteoarthritis, Hip
Eligibility:
All Genders
18+ years
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 th...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 3 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03846791
Start Date
July 15 2019
End Date
May 3 2024
Last Update
August 13 2024
Active Locations (2)
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1
Nuffield Health Bournemouth
Bournemouth, United Kingdom, BH1 1RW
2
Orthopaedic Research Institute Bournemouth University
Bournemouth, United Kingdom, BH8 8FT