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Active, Not Recruiting

NCT Number: NCT05186168

Corin MiniHip and Trinity Cup Clinical Surveillance Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Total Hip Arthroplasty Arthritis Avascular Necrosis of the Femoral Head Bone Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Developmental Dysplasia of the Hip Femur Head Necrosis Hip Dislocation Joint Diseases Joint Dislocations Musculoskeletal Abnormalities Musculoskeletal Diseases Necrosis Osteoarthritis Osteoarthritis, Hip Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis of Hip Traumatic Arthritis of Hip

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MiniHip Stem

Device

The MiniHip stem is a titanium femoral stem (Ti-6Al-4V) coated with a layer of hydroxyapatite applied over a layer of pure titanium

Trinity Acetabular Cup System

Device

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell

Primary outcomes

  1. Post operative survivorship of the Minihip Stem and Trinity acetabular Cup system at 10-year follow-up

    Time frame: 10 years

    Survivorship measured via Kaplan-Meier (KM) curve

Secondary outcomes

  1. Harris Hip Score (HHS) up to 10-year follow-up

    Time frame: Baseline to 10 years

    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.

  2. Oxford Hip Score (OHS) up to 10-year follow-up

    Time frame: Baseline to 10 years

    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.

  3. Hip- and device-related adverse events up to 10-year follow-up

    Time frame: Baseline to 10 years

    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

  4. Trinity acetabular cup radiographic performance up to 10-years

    Time frame: Baseline to 10 years

    Radiographic assessment considering Acetabular radiolucent lines using the De lee Charney measurement of zones 1 - 3.

  5. Minihip Stem radiographic performance up to 10-years

    Time frame: Baseline 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

  6. Minihip Stem and Trinity acetabular cup radiographic performance up to 10-years

    Time frame: Baseline to 10 years

    Radiographic assessment considering heterotopic ossifications using the Brooker classification Grade 1 - 4.

Sponsors and collaborators

Lead sponsor

Corin

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2028
Study completion
2028
First posted
Jan 11, 2022
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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