Clinical trial NCT05186168: Corin MiniHip and Trinity Cup Clinical Surveillance Study
Official title: The Corin MiniHip and Trinity Advanced Bearing Acetabular Cup System UK Clinical Surveillance Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suitable participants undergoing primary total hip replacement with the Corin MiniHip and Trinity Advanced Bearing Acetabular System.

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.

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.

Primary outcomes:
measure: Post operative survivorship of the Minihip Stem and Trinity acetabular Cup system at 10-year follow-up
timeFrame: 10 years
Secondary outcomes:
measure: Harris Hip Score (HHS) up to 10-year follow-up
timeFrame: Baseline to 10 years
measure: Oxford Hip Score (OHS) up to 10-year follow-up
timeFrame: Baseline to 10 years
measure: Hip- and device-related adverse events up to 10-year follow-up
timeFrame: Baseline to 10 years
measure: Trinity acetabular cup radiographic performance up to 10-years
timeFrame: Baseline to 10 years
measure: Minihip Stem radiographic performance up to 10-years
timeFrame: Baseline to 10 years
measure: Minihip Stem and Trinity acetabular cup radiographic performance up to 10-years
timeFrame: Baseline to 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Elective Orthopaedic Centre, Epsom Hospital, Epsom, Surrey, KT18 7EG
name: Richard Field
role: PRINCIPAL_INVESTIGATOR
References: