ProspectiveNCT04350255
A Register Based Prospective Study During Implementation of a New Cup
A study testing Total hip arthroplasty in people with Prospective, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
In a prospective register-based study, we aim to evaluate the implant survival, clinical outcomes and X-ray findings by following a cohort of patients operated with the Trident II cup. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prospective
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2020to 1 Aug 2030
- Phase
- Interventional
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary hip replacement
- Eligible for uncemented fixation of the acetabular component
- Suitable for one of the stem designs from Stryker Orthopaedics
- Accepts follow-up according to the study protocol
Who cannot join
- Difficulties to understand written information due to language problems or other reasons
- Use of augments needed
- Acute hip fracture
- Tumor in the hip joint
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Department of Orthopaedics
Mölndal, Västra Götaland County, S-43180
About this study
Official title: STEISURE - Trident II - A Registerbased Multicentric Prospective Study
In a prospective register-based study, we aim to evaluate the implant survival, clinical outcomes and X-ray findings by following a cohort of patients operated with the Trident II cup.
Read the detailed description
Data will be collected from a cohort consisting of minimum 500 total hip arthroplasties. The patients will be recruited from multiple high volume centers in Sweden. To determine if there is evidence of inferiority as per benchmarking recommendations by The Orthopaedic Data Evaluation Panel the following parameters will be studied: Clinical parameters such as EQ-5D, Oxford Hip Score and Forgotten Joint Score, preoperative and after 1, 3, 6 and 10 years. Conventional radiography will be done preoperatively, postoperatively, 3, 6 and 10 years after total hip replacement. CTMA will be done postoperatively, 3 and 6 month and 2 years after total hip replacement.
- Conditions
- Prospective
- Being tested
- Total hip arthroplasty
- Keywords
- Hip arthroplasty, Implant survival, Clinical outcome, X-ray, Implant Migration, Patient reported outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyDevice
Total hip arthroplasty with a Trident II hemispherical cup
Total hip arthroplastyDevice
Total hip arthroplasty with a Trident II Tritanium cup
| Study group | Role | What they receive |
|---|---|---|
| Trident II Hemispherical cup (Stryker Orthopaedics) | Active comparator | Total hip arthroplasty using non cemented Trident II Hemispherical acetabular cup Receives: Device: Total hip arthroplasty |
| Trident II Tritanium cup (Stryker Orthopaedics) | Active comparator | Total hip arthroplasty using non cemented Trident II Tritanium acetabular cup Receives: Device: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival at 3 years
Kaplan Meier survival data, cup revision and risk of revision used as endpoints
Measured: 3 years
Secondary outcomes (8)
Implant migration measured with Computer Tomography Microanalysis in a subcohort of patients motion Analysis (CTMA) in a sub-cohort of patients
Using Computer Tomography Micro-motion Analysis (CTMA) to measure implant migration in a sub-cohort of patients
Measured: CTMA will be done postoperatively, 3 month and 6 months and 2 years after total hip replacement
Implant survival at 10 years
Kaplan Meier survival data, cup revision and risk of revision used as endpoints
Measured: 10 years
EQ-5D
Patient-reported generic health outcome measure
Measured: 10 years
Plain radiographs in a sub-cohort of patients
Using plain radiographs to evaluate signs of loosening and implant position
Measured: 10 years
Adverse events using the national patient register
ICD codes för surgical and medical adverse events following primary total hip arthroplasty, as defined by the National Board of Health and Welfare will be merged with data in the SHAR (The Swedish Hip Arthroplasty Register). This database includes mainly secondary care visits
Measured: 10 years
Adverse events using the regional VEGA database
ICD (International Classification of Diseases) codes för surgical and medical adverse events following primary total hip arthroplasty, as defined by the National Board of Health and Welfare will be merged with data in the SHAR (The Swedish Hip Arthroplasty Register). This regional database includes all contacts (both within primary and secondary care) for patients living in the region of Western Sweden
Measured: 10 years
Oxford Hip Score
Patient-reported hip specific outcome measure
Measured: 10 years
Forgotten Joint Score
Patient-reported hip specific outcome measure
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Aug 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProspectiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Principal investigator, Maziar Mohaddes Ardebili, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350255
- Sponsor's protocol ID
- STEISURE - Trident II
- Status last verified
- Oct 2022
- First submitted
- 8 Apr 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to regulations associated with national registers in Sweden alla data will be presented on an aggregated level, individual patient data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEISURE - Trident II - A Registerbased Multicentric Prospective Study
- ClinicalTrials.gov ID
- NCT04350255
- Acronym / sponsor ID
- STEISURE - Trident II
- Conditions
- Prospective
- Keywords
- Hip arthroplasty, Implant survival, Clinical outcome, X-ray, Implant Migration, Patient reported outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 17 Apr 2020 (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.
In a prospective register-based study, we aim to evaluate the implant survival, clinical outcomes and X-ray findings by following a cohort of patients operated with the Trident II cup.
Detailed description
Data will be collected from a cohort consisting of minimum 500 total hip arthroplasties. The patients will be recruited from multiple high volume centers in Sweden. To determine if there is evidence of inferiority as per benchmarking recommendations by The Orthopaedic Data Evaluation Panel the following parameters will be studied: Clinical parameters such as EQ-5D, Oxford Hip Score and Forgotten Joint Score, preoperative and after 1, 3, 6 and 10 years. Conventional radiography will be done preoperatively, postoperatively, 3, 6 and 10 years after total hip replacement. CTMA will be done postoperatively, 3 and 6 month and 2 years after total hip replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trident II Hemispherical cup (Stryker Orthopaedics) | Active comparator | Device: Total hip arthroplastyTotal hip arthroplasty using non cemented Trident II Hemispherical acetabular cup |
| Trident II Tritanium cup (Stryker Orthopaedics) | Active comparator | Device: Total hip arthroplastyTotal hip arthroplasty using non cemented Trident II Tritanium acetabular cup |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary hip replacement
- Eligible for uncemented fixation of the acetabular component
- Suitable for one of the stem designs from Stryker Orthopaedics
- Accepts follow-up according to the study protocol
Key exclusion criteria (4 listed)
- Difficulties to understand written information due to language problems or other reasons
- Use of augments needed
- Acute hip fracture
- Tumor in the hip joint
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 |
|---|---|---|
| Total hip arthroplastyTotal hip arthroplasty with a Trident II hemispherical cup | Device | Trident II Hemispherical cup (Stryker Orthopaedics), Trident II Tritanium cup (Stryker Orthopaedics) |
| Total hip arthroplastyTotal hip arthroplasty with a Trident II Tritanium cup | Device | Trident II Hemispherical cup (Stryker Orthopaedics), Trident II Tritanium cup (Stryker Orthopaedics) |
Primary outcome
Implant survival at 3 years
Time frame: 3 years
Kaplan Meier survival data, cup revision and risk of revision used as endpoints
8 secondary outcomes
Implant migration measured with Computer Tomography Microanalysis in a subcohort of patients motion Analysis (CTMA) in a sub-cohort of patients
Time frame: CTMA will be done postoperatively, 3 month and 6 months and 2 years after total hip replacement
Implant survival at 10 years
Time frame: 10 years
EQ-5D
Time frame: 10 years
Plain radiographs in a sub-cohort of patients
Time frame: 10 years
Adverse events using the national patient register
Time frame: 10 years
Adverse events using the regional VEGA database
Time frame: 10 years
Oxford Hip Score
Time frame: 10 years
Forgotten Joint Score
Time frame: 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 4 Oct 2022.
- Individual participant dataSharing planned: No. Due to regulations associated with national registers in Sweden alla data will be presented on an aggregated level, individual patient data will not be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip arthroplasty in people with Prospective, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 4 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: looking for participants now, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Maziar Mohaddes, MD, PhD (+46730701147, maziar.mohaddes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival at 3 years (time frame: 3 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 4 Oct 2022.