Hip Replacement ArthroplastyNCT03724058
Fixation and Stability of the Trident® II Clusterhole HA Shells
A study testing Trident® II Clusterhole HA Acetabular Shell and Trident® Hemispherical Acetabular Shell in people with Hip Replacement Arthroplasty, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of the Trident® II project is to introduce a cup system that modernizes and streamlines Stryker's acetabular shell portfolio. The Trident® II Clusterhole HA Shell combines the history of Stryker's Trident® shells with plasma spray CpTi with HA coating. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hip Replacement Arthroplasty
- What is being tested?
- Trident® II Clusterhole HA Acetabular Shell and Trident® Hemispherical Acetabular Shell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSweden
- Study dates
- 6 Feb 2019to 11 May 2031
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is able to understand the meaning of the study and is willing to sign the EC approved, study specific Informed Patient Consent Form.
- The subject is a male or non-pregnant female between 40 and 75 years of age.
- Patients with a BMI < 35.
- Patients requiring uncemented primary THA, suitable for the use of the uncemented Trident® Hemi HA or Trident® II Clusterhole HA acetabular component in combination with any compatible Stryker femoral stem.
- Patients with no clinical relevant disorders undergoing total hip arthroplasty.
- Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or post-traumatic arthritis (TA).
- Patients who are physically and mentally willing and able to comply with postoperative functional evaluation and able to participate in an appropriate rehabilitation schedule.
Who cannot join
- Patients who are unwilling to cooperate with the study protocol and follow-up schedule.
- Patients who, as judged by the surgeon, are mentally incompetent or are likely to be non-compliant with the prescribed post-operative routine and follow-up evaluation schedule.
- Patients with rheumatoid arthritis hip as well as history of acetabular or femoral osteotomy.
- Patients who had a THA on the contra-lateral side within last 6 months.
- Patients who had or will need lower joint replacement for another joint within 6 month
- Female patients that are pregnant or planning a pregnancy during the course of the study
Show all 12Show fewer
- Patients who require revision of a previously implanted THA.
- Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2 > 35)
- Patients with active or suspected infection
- Patients with active malignancy
- Patients with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (severe osteoporosis, Paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose.
- Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Orthopaedics Hässleholm-Kristianstad-Ystad, Hässleholm Hospital
Hässleholm, 28138
About this study
Official title: Fixation and Stability of the Trident® II Clusterhole HA Shells Compared to the Trident® Hemi HA Shells With X3. A Single Center RSA Study
The purpose of the Trident® II project is to introduce a cup system that modernizes and streamlines Stryker's acetabular shell portfolio. The Trident® II Clusterhole HA Shell combines the history of Stryker's Trident® shells with plasma spray CpTi with HA coating. Plasma spray coating and HA is considered to be the gold standard in orthopaedics today. This coating will help the cup to achieve early stability and long term fixation.
One of the causes for implant failure is loosening and osteolysis. Osteolysis can be triggered when metal or polyethylene wear particles from the implant or bearing surfaces migrate between implant and surrounding host bone tissue. With the development of sequential irradiated and annealed highly crosslinked polyethylene (X3) wear rates (mean proximal, 2-dimensional and 3-dimensional) have been substantially reduced to 0.001 mm/y, calculated between 1 year and 5 years.
Read more
The Trident® II Clusterhole HA shells have a plasma sprayed CpTi coating compared to the arc-deposition CpTi coating on legacy Trident® shells, both designed to allow bone ongrowth. With this study the investigators want to prove equivalent implant fixation of both type of cups.
The primary objective is the assessment of prosthetic fixation and migration results after two years of the Trident® II Clusterhole HA shell compared to the legacy Trident® Hemi HA shell by means of RSA. It is hypothesized that they will perform equally.
The secondary outcome measure will be long-term (10-year) survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10-year results will be used to verify the predicted long-term survival results.
- Conditions
- Hip Replacement Arthroplasty
- Being tested
- Trident® II Clusterhole HA Acetabular Shell, Trident® Hemispherical Acetabular Shell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trident® II Clusterhole HA Acetabular ShellDevice
Also called Stryker Orthopaedics
Hip arthroplasty
Trident® Hemispherical Acetabular ShellDevice
Also called Stryker Orthopaedics
Hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Trident® II Clusterhole HA Acetabular Shell | Experimental | Hip arthroplasty using Trident II Clusterhole HA Acetabular Shells Receives: Device: Trident® II Clusterhole HA Acetabular Shell |
| Trident® Hemispherical Acetabular Shell | Active comparator | Hip arthroplasty using Trident Hemispherical Acetabular Shell Receives: Device: Trident® Hemispherical Acetabular Shell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration, measured by means of RSA
Migration (MTPM in mm) of the prosthesis with respect to the host bone
Measured: 2 years
Secondary outcomes (5)
Migration, measured by means of RSA
Migration (MTPM in mm) of the prosthesis with respect to the host bone
Measured: 10 years
Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire
The EQ-5D-3L consists of questions covering five dimensions measuring the patient's mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each question with three levels of possible answers and a single index value for health status. Health status has a range from 1 to 100.
Measured: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with the Forgotten Joint Score (FJS) patient questionnaire.
The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The FJS uses a 5-grade Likert scale ranging from "Never" to "Mostly". The score has a range of 0-100.
Measured: 3 months, 1, 2, 5, 7 and 10 years
Investigation of the patients' opinion about their hip and associated problems with HOOS (Hip disability and Osteoarthritis Outcome Score).
HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The HOOS uses a 5-grade Likert scale and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of patient outcome with radiographic analysis
Plain radiographs will be obtained for assessment of fixation of the device.
Measured: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start6 Feb 2019
- Primary completion5 Jun 2023
- Study completion11 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Replacement ArthroplastyStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724058
- Sponsor's protocol ID
- H-I-104
- Status last verified
- Sep 2025
- First submitted
- 26 Oct 2018
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation and Stability of the Trident® II Clusterhole HA Shells Compared to the Trident® Hemi HA Shells With X3. A Single Center RSA Study
- ClinicalTrials.gov ID
- NCT03724058
- Acronym / sponsor ID
- H-I-104
- Conditions
- Hip Replacement Arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 11 May 2031 (estimated)
- First posted
- 30 Oct 2018 (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 purpose of the Trident® II project is to introduce a cup system that modernizes and streamlines Stryker's acetabular shell portfolio. The Trident® II Clusterhole HA Shell combines the history of Stryker's Trident® shells with plasma spray CpTi with HA coating. Plasma spray coating and HA is considered to be the gold standard in orthopaedics today. This coating will help the cup to achieve early stability and long term fixation.
One of the causes for implant failure is loosening and osteolysis. Osteolysis can be triggered when metal or polyethylene wear particles from the implant or bearing surfaces migrate between implant and surrounding host bone tissue. With the development of sequential irradiated and annealed highly crosslinked polyethylene (X3) wear rates (mean proximal, 2-dimensional and 3-dimensional) have been substantially reduced to 0.001 mm/y, calculated between 1 year and 5 years.
The Trident® II Clusterhole HA shells have a plasma sprayed CpTi coating compared to the arc-deposition CpTi coating on legacy Trident® shells, both designed to allow bone ongrowth. With this study the investigators want to prove equivalent implant fixation of both type of cups.
The primary objective is the assessment of prosthetic fixation and migration results after two years of the Trident® II Clusterhole HA shell compared to the legacy Trident® Hemi HA shell by means of RSA. It is hypothesized that they will perform equally.
The secondary outcome measure will be long-term (10-year) survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10-year results will be used to verify the predicted long-term survival results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trident® II Clusterhole HA Acetabular Shell | Experimental | Device: Trident® II Clusterhole HA Acetabular ShellHip arthroplasty using Trident II Clusterhole HA Acetabular Shells |
| Trident® Hemispherical Acetabular Shell | Active comparator | Device: Trident® Hemispherical Acetabular ShellHip arthroplasty using Trident Hemispherical Acetabular Shell |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is able to understand the meaning of the study and is willing to sign the EC approved, study specific Informed Patient Consent Form.
- The subject is a male or non-pregnant female between 40 and 75 years of age.
- Patients with a BMI < 35.
- Patients requiring uncemented primary THA, suitable for the use of the uncemented Trident® Hemi HA or Trident® II Clusterhole HA acetabular component in combination with any compatible Stryker femoral stem.
- Patients with no clinical relevant disorders undergoing total hip arthroplasty.
Key exclusion criteria (12 listed)
- Patients who are unwilling to cooperate with the study protocol and follow-up schedule.
- Patients who, as judged by the surgeon, are mentally incompetent or are likely to be non-compliant with the prescribed post-operative routine and follow-up evaluation schedule.
- Patients with rheumatoid arthritis hip as well as history of acetabular or femoral osteotomy.
- Patients who had a THA on the contra-lateral side within last 6 months.
- Patients who had or will need lower joint replacement for another joint within 6 month
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 |
|---|---|---|
| Trident® II Clusterhole HA Acetabular ShellAlso: Stryker OrthopaedicsHip arthroplasty | Device | Trident® II Clusterhole HA Acetabular Shell |
| Trident® Hemispherical Acetabular ShellAlso: Stryker OrthopaedicsHip arthroplasty | Device | Trident® Hemispherical Acetabular Shell |
Primary outcome
Migration, measured by means of RSA
Time frame: 2 years
Migration (MTPM in mm) of the prosthesis with respect to the host bone
5 secondary outcomes
Migration, measured by means of RSA
Time frame: 10 years
Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with the Forgotten Joint Score (FJS) patient questionnaire.
Time frame: 3 months, 1, 2, 5, 7 and 10 years
Investigation of the patients' opinion about their hip and associated problems with HOOS (Hip disability and Osteoarthritis Outcome Score).
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of patient outcome with radiographic analysis
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 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 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trident® II Clusterhole HA Acetabular Shell and Trident® Hemispherical Acetabular Shell in people with Hip Replacement Arthroplasty, run by Region Skane 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 7 inclusion and 12 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 4 Sep 2025. 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?
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?
Migration, measured by means of RSA (time frame: 2 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 Sep 2025.