Hip Disease
Conditions
Keywords
Total Hip Replacement, Patient reported outcome measures, Post Market Clinical Follow-up / Post Market Surveillance
Brief summary
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, and involves replacing both the hip ball and socket. Its goal is to provide pain relief, allowing the person to return to a normal lifestyle. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has a H-A.C. coating to promote ossoeintegration of the device within the host bone. To increase the surgeons choice and thus suitability for the patient, there is the option of 3 different socket liners (ceramic, polymer or dual mobility). To ensure maximum safety and performance of medical devices surveillance of the device should be carried out over the devices lifetime. This study is a 10 year surveillance study to assess the clinical, functional and radiological outcomes of the CE-marked ACE Acetabular Cup System. This is done by examining patient outcomes through questionnaires, reviews of X-rays and complications by patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.
Interventions
DEVICETotal Hip Replacement
Primary elective total hip replacement
Sponsors
JRI Orthopaedics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients deemed suitable for elective primary THR, as per indications in the IFU. * Male or female, 18 years or older.
Exclusion criteria
* Patients who are unable to provide written informed consent. * Patients deemed unsuitable for THR, as per contra-indications in the IFU. * Patients indicated for THR as a result of trauma (i.e. neck of femur fracture). * Patients who are pregnant (
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Hip Score | 3 years post-op | A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survivorship | 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op | Implant survivorship based on revision rate and determined using the Kaplan-Meier analysis method |
| Oxford Hip Score | 6 months, 1 year, 5 years, 7 years and 10 years post-op | A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best) |
| EQ-5D-5L | 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op | A patient completed functional score to assess quality of life of the patient. Score range: -0.594 (worse) to 1.0 (best). |
| Radiological Assessment | 1 year, 5 years and 10 years post-op | Radiographs reviewed for signs of radiolucencies, osteolysis, sclerosis and atrophy around the device |
| Modified Harris Hip Score | 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op | A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 100 (best) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Device Effects | 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op | Trends and anaylsis or adverse device effects reported |
Countries
United Kingdom
Outcome results
None listed