Corin MiniHip and Trinity Cup Clinical Surveillance Study

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to provide long term follow up data on the performance and safety of the Corin MiniHip and Trinity acetabular cup over a 10-year period.

Detailed Description
-----------------
To verify the ten-year clinical and radiographic performance of the Corin MiniHip and Trinity Advanced Bearing Acetabular System when used in patients under normal conditions of use. To document the safety, evaluate patient satisfaction, quality of life and to determine the survivorship following intervention with the Corin MiniHip and Trinity Advanced Bearing Acetabular System at each follow-up visit.

Official Title
-----------------
The Corin MiniHip and Trinity Advanced Bearing Acetabular Cup System UK Clinical Surveillance Study

Conditions
-----------------
Total Hip Arthroplasty, Osteoarthritis, Hip, Traumatic Arthritis of Hip, Rheumatoid Arthritis of Hip, Developmental Dysplasia of the Hip, Avascular Necrosis of the Femoral Head

Intervention / Treatment
-----------------
* Device: MiniHip Stem
* Device: Trinity Acetabular Cup System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or developmental dysplasia of the hip. Avascular necrosis of the femoral head All subjects must be between the age of 18 and 75 at the time of surgery to take part in this study Scheduled for a primary total hip replacement. Exclusion Criteria: Active infection Severe Obesity (BMI over 35) Pregnancy Mental illness Grossly distorted anatomy (surgeon's discretion) Sepsis Osteomyelitis Osteomalacia Distant foci of infections Osteoporosis Metabolic disorders which may impair bone formation Muscular atrophy or neuromuscular disease Allergy to implant material Marked bone loss or bone resorption Patients without sufficient quantities of synovial fluid to allow for proper lubrication, such as patients with Sjogren's syndrome Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock or poor skin coverage around the hip joint which would make the procedure inappropriate Any case not described in the inclusion criteria Any patient who cannot or will not provide informed consent for participation in the study Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MiniHip Stem|The MiniHip stem is a titanium femoral stem (Ti-6Al-4V) coated with a layer of hydroxyapatite applied over a layer of pure titanium|
|Device: Trinity Acetabular Cup System|The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative survivorship of the Minihip Stem and Trinity acetabular Cup system at 10-year follow-up | Survivorship measured via Kaplan-Meier (KM) curve | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score (HHS) up to 10-year follow-up | Harris Hip Score is a disease-specific scoring system, originally intended as an outcome score after arthroplasty surgeries that includes the domains of function, pain, motion and deformity. Minimum score is 0, Maximum score is 100. The score is reported as 90-100 for excellent results, 80-89 for good, 70-79 for fair, 60-69 for poor, and below 60 for a failed result. | Baseline to 10 years | 
| Oxford Hip Score (OHS) up to 10-year follow-up | Oxford Hip Score is a patient-centered questionnaire that is designed to assess functional ability and pain from the patient's perspective. It is a short, twelve-item questionnaire developed for completion by patients undergoing THA. Minimum score 0 indicating worst outcome, maximum score 48 indicating best outcome. | Baseline to 10 years | 
| Hip- and device-related adverse events up to 10-year follow-up | All hip-related and device-related complications, including those occurring during the surgical procedure and throughout the postoperative evaluations, are required to be documented and reviewed | Baseline to 10 years | 
| Trinity acetabular cup radiographic performance up to 10-years | Radiographic assessment considering Acetabular radiolucent lines using the De lee Charney measurement of zones 1 - 3. | Baseline to 10 years | 
| Minihip Stem radiographic performance up to 10-years | Radiographic assessment considering osteolysis and femoral stem alignment measured as Varus/Valgus and the use of the Gruen's assessment zones 1-7 | Baseline to 10 years | 
| Minihip Stem and Trinity acetabular cup radiographic performance up to 10-years | Radiographic assessment considering heterotopic ossifications using the Brooker classification Grade 1 - 4. | Baseline to 10 years |