Total Hip ArthroplastyNCT05186168
Corin MiniHip and Trinity Cup Clinical Surveillance Study
An observational study of Total Hip Arthroplasty and Osteoarthritis, Hip, run by Corin.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Hip Arthroplasty, Osteoarthritis, Hip, Traumatic Arthritis of Hip
- What is being tested?
- MiniHip Stem and Trinity Acetabular Cup System
- Type of treatment
- Medical device
- How many people
- 546 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2011to 3 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suitable participants undergoing primary total hip replacement with the Corin MiniHip and Trinity Advanced Bearing Acetabular System.
Who may be able to join
- 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.
Who cannot join
- Active infection
- Severe Obesity (BMI over 35)
- Pregnancy
- Mental illness
- Grossly distorted anatomy (surgeon's discretion)
- Sepsis
Show all 19Show fewer
- 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.
About this study
Official title: The Corin MiniHip and Trinity Advanced Bearing Acetabular Cup System UK 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.
Read the 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.
- 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
- Being tested
- MiniHip Stem, Trinity Acetabular Cup System
- Medical subject headings
- Osteoarthritis, Hip, Developmental Dysplasia of the Hip, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniHip StemDevice
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 SystemDevice
The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative survivorship of the Minihip Stem and Trinity acetabular Cup system at 10-year follow-up
Survivorship measured via Kaplan-Meier (KM) curve
Measured: 10 years
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start15 Mar 2011
- Primary completion3 May 2028 (estimated)
- Study completion3 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Field, Principal investigator, Elective Orthopaedic Centre, Epsom Hospital, Epsom, Surrey, KT18 7EG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186168
- Sponsor's protocol ID
- MH101
- Status last verified
- Aug 2023
- First submitted
- 15 Dec 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Corin MiniHip and Trinity Advanced Bearing Acetabular Cup System UK Clinical Surveillance Study
- ClinicalTrials.gov ID
- NCT05186168
- Acronym / sponsor ID
- MH101
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 546 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2011 (actual)
- Primary completion
- 3 May 2028 (estimated)
- Study completion
- 3 May 2028 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suitable participants undergoing primary total hip replacement with the Corin MiniHip and Trinity Advanced Bearing Acetabular System.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- Active infection
- Severe Obesity (BMI over 35)
- Pregnancy
- Mental illness
- Grossly distorted anatomy (surgeon's discretion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiniHip StemThe 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 SystemThe Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell | Device | – |
Primary outcome
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
6 secondary outcomes
Harris Hip Score (HHS) up to 10-year follow-up
Time frame: Baseline to 10 years
Oxford Hip Score (OHS) up to 10-year follow-up
Time frame: Baseline to 10 years
Hip- and device-related adverse events up to 10-year follow-up
Time frame: Baseline to 10 years
Trinity acetabular cup radiographic performance up to 10-years
Time frame: Baseline to 10 years
Minihip Stem radiographic performance up to 10-years
Time frame: Baseline to 10 years
Minihip Stem and Trinity acetabular cup radiographic performance up to 10-years
Time frame: Baseline to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Field principal investigator
Elective Orthopaedic Centre, Epsom Hospital, Epsom, Surrey, KT18 7EG
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty and Osteoarthritis, Hip, run by Corin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative survivorship of the Minihip Stem and Trinity acetabular Cup system at 10-year follow-up (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.