Total hip arthroplasty Surgery
Conditions
Interventions
Current interventions as of 08/10/2025:
Participants will undergo hip replacement surgery with a Trident® II 3D printed acetabular component.
Patients will be included in the study for up to 6 years
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant female between 40 and 75 years of age with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or post-traumatic arthritis (PTA) and requiring primary THA and is suitable for the use for the uncemented Trident II acetabular component, in combination with any Stryker liner and any compatible femoral head and stem. 2. Patients who are physically and mentally willing and able to comply with the post-operative follow-ups and an appropriate rehabilitation schedule. 3. Patient is able to understand and provide written consent. 4. Patients with no clinically relevant disorders undergoing THA.
Exclusion criteria
Exclusion criteria: 1. Patients deemed by the treating surgeon to be unable to comply with the prescribed post-operative routine and follow-up evaluation schedule. 2. Patients with rheumatoid arthritic hip as well as history of acetabular or femoral osteotomy. 3. Patients who have had a THA on the contra-lateral side within last 6 months. 4. Patients who are likely to need further lower limb joint replacement for another joint within one year. 5. Female patients between the ages of 40 and 75 years that are pregnant or planning a pregnancy up to 1 year during which they would have received the implant. 6. Patients who require revision of previously implanted THA. 7. Patients with active or suspected infection, requiring treatment. 8. Patients with active malignancy. 9. Patients diagnosed with systemic disease that would affect patient’s welfare or overall outcome of the study (severe osteoporosis, Paget’s Disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose. 10. Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient’s ability to limit weight bearing or places an extreme load on the implant during the healing period. 11. Patients with systemic or metabolic disorders leading to progressive bone deterioration (such as rickets, osteomalacia, osteogenesis, imperfecta, marble bone disease, (osteopetrosis), Paget disease of bone and fibrous dysplasia). 12. Patients with other concurrent illnesses which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus, psoriasis or renal disease requiring dialysis. 13. Patients with a body mass index (BMI), kg/m² > 40. Obese patients where obesity is severe enough to affect patient’s ability to perform activities of daily living. 14. Is the patient involved in a research study that, in the opinion of the PI, would affect their continued participation in the previous study and/or would affect the current study intervention and/or their treatment outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient reported outcome measures (PROMs) assessing symptoms and functional limitations measured using the Oxford Hip Score (OHS) at baseline and at 1 year post-operatively 2. Device survivorship measured by clinical assessment (rates of re-operation and revision, including any adverse events) at 1 year post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/10/2025: 1. PROMs assessing symptoms and functional limitations measured using the Oxford Hip Score (OHS): pre-operative and 6-12 weeks, 1 year, and 5 years post-operative 2. PROMs assessing awareness of artificial joint in everyday life measured using the Forgotten Joint Score (FJS): pre-operative and 6-12 weeks, 1 year, and 5 years post-operative 3. PROMs assessing health outcome and quality of life measured using the EQ5D5L: pre-operative and 6-12 weeks, 1 year, and 5 years post-operative 4. Device survivorship measured by clinical assessment (rates of re-operation and revision, including any adverse events) prior to discharge (PTD), 6-12 weeks, 1 year, and 5 years post-operative. Radiographic assessment will also be collected as part of device survivorship and national recommendations of the British Orthopaedic Association (BOA) for follow-up of a new implant, collected: pre-operative, PTD, 1 year post-operative Previous secondary outcome measures: 1. PROMs assessing symptoms and functional limitations measured using the Oxford Hip Score (OHS): pre-operative and 6-12 weeks, 1 year, 3 years, 5 years, 7 years and 10 years post-operative 2. PROMs assessing awareness of artificial joint in everyday life measured using the Forgotten Joint Score (FJS): pre-operative and 6-12 weeks, 1 year, 3 years, 5 years, 7 years and 10 years post-operative 3. PROMs assessing health outcome and quality of life measured using the EQ5D5L: pre-operative and 6-12 weeks, 1 year, 3 years, 5 years, 7 years and 10 years post-operative 4. Device survivorship measured by clinical assessment (rates of re-operation and revision, including any adverse events) prior to discharge (PTD), 6-12 weeks, 1 year, 5 years and 10 years post-operative. Radiographic assessment will also be collected as part of device survivorship and national recommendations of the British Orthopaedic Association (BOA) for follow-up of a new implant, collected: pre-operative, PT | — |
Countries
England, United Kingdom
Outcome results
None listed