Corin MiniHip and Trinity Cup Clinical Surveillance Study

NCT05186168 | Active Not Recruiting FDA Device

• 1 other identifier: MH101
• Study Type: observational
• Target: 546
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  Baseline to 10 years

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

  Baseline to 10 years

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

  Baseline to 10 years

• Trinity acetabular cup radiographic performance up to 10-years

  Baseline to 10 years

• Minihip Stem radiographic performance up to 10-years

  Baseline to 10 years

Interventions

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Suitable participants undergoing primary total hip replacement with the Corin MiniHip and Trinity Advanced Bearing Acetabular System.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corin: lead

MeSH Terms

Conditions

Osteoarthritis, Hip; Developmental Dysplasia of the Hip; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Hip Dislocation; Joint Dislocations; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Field

  Elective Orthopaedic Centre, Epsom Hospital, Epsom, Surrey, KT18 7EG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 11, 2022
• Study Start: March 15, 2011
• Primary Completion (Estimated): May 3, 2028
• Study Completion (Estimated): May 3, 2028
• Last Updated: September 1, 2023

Record last verified: 2023-08