End-stage joint disease e.g. osteoarthritis, requiring hip joint replacement Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient suitable for hip resurfacing arthroplasty 2. Patient able to give informed consent 3. Patient willing and able to take part in the study for the prescribed length of the study 4. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study 5. Minimum age of 18 years
Exclusion criteria
Exclusion criteria: 1. Patient deemed unsuitable for hip resurfacing arthroplasty by the surgeon 2. Patient has significant contraindications when following the manufacturer's Instruction For Use of the product 3. Patient likely to become incapacitated during the study 4. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proximal migration measured by RSA at 12 months 2. Hip function measured using the Oxford Hip Score at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Migration measured by RSA at 6 and 24 months 2. Hip function measured using the Oxford Hip Score at 12 and 24 months 3. Rate of adverse events collected by research team as they occur (all times to 24 month) 4. Revision rate (i.e device failure rate) measured by research team as they occur (all times to 24 month) 5. Additional PROMs (pre-op, 6, 12 and 24 months): 5.1. Hip function (Oxford Hip Score) 5.2. Quality of life (EQ5D) 5.3. Hip symptoms (HOOS) 5.4. Activity (UCLA Activity Scale) 5.5. Satisfaction score (using a novel 4 item questionnaire) 5.6. Single question on joint awareness | — |
Countries
England, Scotland, United Kingdom