Total Hip ArthroplastyNCT03261986
A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup
A study testing Radiostereometric Analysis and total hip arthroplasty with RSA bead implantation in people with Total Hip Arthroplasty and Acetabular Cup, run by Midwest Orthopaedics at Rush at 1 site in United States.
Trial summary
The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome measures to evaluate early post-operative implant stability and the clinical performance of Stryker's Trident II Acetabular Cup. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Hip Arthroplasty, Acetabular Cup
- What is being tested?
- Radiostereometric Analysis and total hip arthroplasty with RSA bead implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2017to 9 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic arthritis of the hip indicating surgical intervention
- Scheduled to undergo a primary total hip arthroplasty
- Patient is a candidate for the Trident II acetabular cup in accordance with product labeling -
Who cannot join
- Patients less than 18 years of age, or older than 85 years of age.
- Severe hip dysplasia (Crowe Type III or IV) in the affected hip
- History of congenital dislocation
- Prior arthroplasty of the affected hip
- Active or prior infection of the affected hip
- Morbid obesity (BMI > 40)
Show all 13Show fewer
- Medical condition precluding major surgery
- Severe osteoporosis
- Neuromuscular impairment
- Patients with known allergy to metals
- Pregnancy
- Patients on dialysis or creatinine > 2.0
- Patient is immuno-suppressed -
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwest Orthopaedics at Rush
Naperville, Illinois, 60563
About this study
The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome measures to evaluate early post-operative implant stability and the clinical performance of Stryker's Trident II Acetabular Cup.
Read the detailed description
The proposed study is a prospective evaluation of data from patients undergoing primary total hip arthroplasty using the Trident II acetabular cup. Fifty patients will be recruited for this study. All patients that qualify for the study per the inclusion-exclusion criteria and provide written informed consent will receive the Trident II acetabular cup and RSA beads. Implant stability, through RSA, will be measured throughout the first two postoperative (post-op) years per the following schedule: immediate post-op and 6 weeks, 3 months, 6 months, 1 year, and 2 years following surgery. Patients will be discharged and seen for follow-up assessments as per standard of care. Adverse events that are related to the index joint will be collected. Health outcome questionnaires will be collected. The health outcome questionnaires will include: EQ-5D, HOOS JR and Harris Hip Score. Health outcome questionnaires will be completed pre-operatively and again at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery. Conventional x-ray analysis will be performed pre-operatively and again at 6 weeks, 1 year and 2 years following surgery.
- Conditions
- Total Hip Arthroplasty, Acetabular Cup
- Being tested
- Radiostereometric Analysis, total hip arthroplasty with RSA bead implantation
- Keywords
- Trident, RSA, THA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiostereometric AnalysisRadiation
RSA exams of the operative hip are received post-op day 1, and at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery
total hip arthroplasty with RSA bead implantationProcedure or surgery
Patients receive RSA beads inserted into the bone surrounding the Trident II implant.
| Study group | Role | What they receive |
|---|---|---|
| Trident II acetabular cup | Other | Subjects receive the Trident II acetabular cup and RSA beads and undergo a series of post-operative RSA exams. Receives: Radiation: Radiostereometric Analysis; Procedure: total hip arthroplasty with RSA bead implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does the Trident II Cup achieve acceptable fixation to the underlying bone?
The Trident II Cup proximal migration will be assessed. Migration of less than 0.2mm at 2 years and without continuous migration between post-operative year 1 and 2 will indicate acceptable fixation.
Measured: 3 years
Secondary outcomes (5)
What are the migration patterns of the Trident II acetabular cup over the first two post-operative years?
Migration patterns will be assessed using RSA analysis.
Measured: 3 years
Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?
The health status and functional outcome will be assessed via Harris Hip Score.
Measured: 3 years
Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?
The health status and functional outcome will be assessed via EQ-5D.
Measured: 3 years
Is there a correlation between radiolucent lines measured by Charnley-DeLee zone analysis and migration characteristics using RSA?
X-ray radiographs will be taken at pre-op, 6 weeks, 1 year and 2 year appointments. It may take up to 3 years after study start for all patients to reach the 2 year visit mark, depending on how long enrollment takes.
Measured: 3 years
Can inducible displacements measured at 1 year post-operative distinguish patients identified by RSA measurements as having inadequate fixation?
Inducible displacements will be measured using RSA exams at the 1 year follow-up. It may take up to 2 years after study start for all patients to reach the 1 year visit mark, depending on how long enrollment takes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start9 Jun 2017
- Primary completion9 Oct 2020 (estimated)
- Study completion9 Feb 2022 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Orthopaedics at Rush
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Sporer, MD, Principal investigator, Midwest Orthopaedics at Rush
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261986
- Sponsor's protocol ID
- 17-066
- Status last verified
- Mar 2020
- First submitted
- 23 Aug 2017
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup
- ClinicalTrials.gov ID
- NCT03261986
- Acronym / sponsor ID
- 17-066
- Conditions
- Total Hip Arthroplasty, Acetabular Cup
- Keywords
- Trident, RSA, THA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Midwest Orthopaedics at RushUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 9 Oct 2020 (estimated)
- Study completion
- 9 Feb 2022 (estimated)
- First posted
- 25 Aug 2017 (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 objective of this study is to use radiostereometric analysis (RSA) and clinical outcome measures to evaluate early post-operative implant stability and the clinical performance of Stryker's Trident II Acetabular Cup.
Detailed description
The proposed study is a prospective evaluation of data from patients undergoing primary total hip arthroplasty using the Trident II acetabular cup. Fifty patients will be recruited for this study. All patients that qualify for the study per the inclusion-exclusion criteria and provide written informed consent will receive the Trident II acetabular cup and RSA beads. Implant stability, through RSA, will be measured throughout the first two postoperative (post-op) years per the following schedule: immediate post-op and 6 weeks, 3 months, 6 months, 1 year, and 2 years following surgery. Patients will be discharged and seen for follow-up assessments as per standard of care. Adverse events that are related to the index joint will be collected. Health outcome questionnaires will be collected. The health outcome questionnaires will include: EQ-5D, HOOS JR and Harris Hip Score. Health outcome questionnaires will be completed pre-operatively and again at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery. Conventional x-ray analysis will be performed pre-operatively and again at 6 weeks, 1 year and 2 years following surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trident II acetabular cup | Other | Radiation: Radiostereometric Analysis, Procedure: total hip arthroplasty with RSA bead implantationSubjects receive the Trident II acetabular cup and RSA beads and undergo a series of post-operative RSA exams. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic arthritis of the hip indicating surgical intervention
- Scheduled to undergo a primary total hip arthroplasty
- Patient is a candidate for the Trident II acetabular cup in accordance with product labeling -
Key exclusion criteria (13 listed)
- Patients less than 18 years of age, or older than 85 years of age.
- Severe hip dysplasia (Crowe Type III or IV) in the affected hip
- History of congenital dislocation
- Prior arthroplasty of the affected hip
- Active or prior infection of the affected hip
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 |
|---|---|---|
| Radiostereometric AnalysisRSA exams of the operative hip are received post-op day 1, and at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery | Radiation | Trident II acetabular cup |
| total hip arthroplasty with RSA bead implantationPatients receive RSA beads inserted into the bone surrounding the Trident II implant. | Procedure or surgery | Trident II acetabular cup |
Primary outcome
Does the Trident II Cup achieve acceptable fixation to the underlying bone?
Time frame: 3 years
The Trident II Cup proximal migration will be assessed. Migration of less than 0.2mm at 2 years and without continuous migration between post-operative year 1 and 2 will indicate acceptable fixation.
5 secondary outcomes
What are the migration patterns of the Trident II acetabular cup over the first two post-operative years?
Time frame: 3 years
Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?
Time frame: 3 years
Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?
Time frame: 3 years
Is there a correlation between radiolucent lines measured by Charnley-DeLee zone analysis and migration characteristics using RSA?
Time frame: 3 years
Can inducible displacements measured at 1 year post-operative distinguish patients identified by RSA measurements as having inadequate fixation?
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Total Hip Arthroplasty
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Hip Osteoarthritis
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)
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.
Scott Sporer, MD principal investigator
Midwest Orthopaedics at Rush
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiostereometric Analysis and total hip arthroplasty with RSA bead implantation in people with Total Hip Arthroplasty and Acetabular Cup, run by Midwest Orthopaedics at Rush at 1 site in United States.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 Mar 2020. 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 United States. 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?
Results are not available in the source record.
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?
Does the Trident II Cup achieve acceptable fixation to the underlying bone? (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 17 Mar 2020.