Arthroplasty, Replacement, HipX3largeheadsNCT02525627
A Comparative Study of In-vivo Wear Between 28 mm and 40 mm Metal Heads
A study testing Trident cup, X3 inserts, 28 mm head, Trident cup, X3 inserts, 40 mm head and Symax stem in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 1 site in Netherlands.
Trial summary
Prospective, single centre, randomized clinical study; series of patients with a 5-years patient evaluation period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Trident cup, X3 inserts, 28 mm head, Trident cup, X3 inserts, 40 mm head and Symax stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2010to 12 Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Male and non pregnant female patients between 18-75 years of age.
- Patients requiring uncemented primary total hip arthroplasty (THA), suitable for the use of the Symax stem
- Patients with a diagnosis of osteoarthritis (OA), rheumatoid arthritis (RA), avascular necrosis (AVN) or post-traumatic arthritis (TA).
- Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
- Patients who signed the specific Informed Consent Form prior to surgery
Who cannot join
- Patients who require revision of a previously implanted THA
- Patients who had a THA on contra-lateral side within the last 1 year.
- Patients who had a THA on contralateral side more than 1 year ago and the rehabilitation period outcome was considered unsatisfactory or not good. (Patients with contra-lateral THA > 1 year ago with good outcome (Harris Hip Score > 85) can be included in the study).
- Patients who will need lower limb joint replacement for another joint within one year.
- Bilaterally operated patient.
- Patients who have had a prior procedure of acetabular osteotomy.
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- Patients with active or suspected infection.
- Patients with malignancy - active malignancy
- Patients with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. severe osteoporosis, Paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
- The patient has 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 interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
- Female patients planning a pregnancy during the course of the study.
- Patients with systemic or metabolic disorders leading to progressive bone deterioration.
- Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
- Patients with other severe concurrent joint involvements which can affect their outcome.
- Patients with other concurrent illnesses which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus, psoriasis, Insulin dependent Type I diabetes or renal disease requiring dialysis.
- Surgeries to be performed with navigation and/or robot-assisted instruments.
- Patient with a known sensitivity to device materials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of In-vivo Wear Between 28 mm and 40 mm Metal Heads With Highly Cross Linked (X3) Acetabular Polyethylene Insert in the Hemispherical Trident Cup
Prospective, single centre, randomized clinical study; series of patients with a 5-years patient evaluation period.
Read the detailed description
This is a single centre randomized clinical outcomes study. The Symax stem or Accolade TMZF (Titan, Molybdenum, Zirconium, Ferrum) in combination with the Hemispherical Trident cup, X3 inserts, 28 and 40 mm Metal heads are the primary components to be implanted for evaluation.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Trident cup, X3 inserts, 28 mm head, Trident cup, X3 inserts, 40 mm head, Symax stem, Accolade TMZF stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trident cup, X3 inserts, 28 mm headDevice
Orthopaedic implant
Trident cup, X3 inserts, 40 mm headDevice
Orthopaedic implant
Symax stemDevice
Orthopaedic implant
Accolade TMZF stemDevice
Orthopaedic implant
| Study group | Role | What they receive |
|---|---|---|
| Trident cup, X3 inserts, 28 mm head | Active comparator | Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem. Receives: Device: Trident cup, X3 inserts, 28 mm head; Device: Symax stem; Device: Accolade TMZF stem |
| Trident cup, X3 inserts, 40 mm head | Active comparator | Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem. Receives: Device: Trident cup, X3 inserts, 40 mm head; Device: Symax stem; Device: Accolade TMZF stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare Wear of the Polyethylene X3 Insert Based on Digital Radiographs Using the Hip Analysis Suite (HAS).
Determine equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes using HAS, a software for the determination of polyethylene wear on digital radiographs.
Measured: 5 years follow-up
Secondary outcomes (2)
Harris Hip Score (HHS) Patient Questionnaire
Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor.
Measured: 6 weeks, 3 months, 1, 2 and 5 years
Merle D'Aubergine Score (MdA)
The Merle D'Aubergine-Charnley Score is a simplified clinical scoring system for the hip. The overall score is determined by the sum of scores obtained from each dimension of pain, walking ability and joint mobility. The overall numeric score is given by adding the domain scores. Clinical grades: Excellent, 18, Good 15-17, Fair 13-14, Poor <13.
Measured: 6 weeks, 3 months, 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startOct 2010
- Primary completion12 Jan 2016
- Study completion12 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ide C. Heyligers, MD, Principal investigator, Atrium Medical Center, Heerlen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525627
- Sponsor's protocol ID
- H-S-045
- Acronym
- X3largeheads
- Status last verified
- Feb 2024
- First submitted
- 11 Jun 2015
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of In-vivo Wear Between 28 mm and 40 mm Metal Heads With Highly Cross Linked (X3) Acetabular Polyethylene Insert in the Hemispherical Trident Cup
- ClinicalTrials.gov ID
- NCT02525627
- Acronym / sponsor ID
- X3largeheads / H-S-045
- Conditions
- Arthroplasty, Replacement, Hip
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- 12 Jan 2016 (actual)
- Study completion
- 12 Jan 2016 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Posted 6 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, single centre, randomized clinical study; series of patients with a 5-years patient evaluation period.
Detailed description
This is a single centre randomized clinical outcomes study. The Symax stem or Accolade TMZF (Titan, Molybdenum, Zirconium, Ferrum) in combination with the Hemispherical Trident cup, X3 inserts, 28 and 40 mm Metal heads are the primary components to be implanted for evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trident cup, X3 inserts, 28 mm head | Active comparator | Device: Trident cup, X3 inserts, 28 mm head, Device: Symax stem, Device: Accolade TMZF stemEquality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem. |
| Trident cup, X3 inserts, 40 mm head | Active comparator | Device: Trident cup, X3 inserts, 40 mm head, Device: Symax stem, Device: Accolade TMZF stemEquality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and non pregnant female patients between 18-75 years of age.
- Patients requiring uncemented primary total hip arthroplasty (THA), suitable for the use of the Symax stem
- Patients with a diagnosis of osteoarthritis (OA), rheumatoid arthritis (RA), avascular necrosis (AVN) or post-traumatic arthritis (TA).
- Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
- Patients who signed the specific Informed Consent Form prior to surgery
Key exclusion criteria (17 listed)
- Patients who require revision of a previously implanted THA
- Patients who had a THA on contra-lateral side within the last 1 year.
- Patients who had a THA on contralateral side more than 1 year ago and the rehabilitation period outcome was considered unsatisfactory or not good. (Patients with contra-lateral THA > 1 year ago with good outcome (Harris Hip Score > 85) can be included in the study).
- Patients who will need lower limb joint replacement for another joint within one year.
- Bilaterally operated patient.
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 cup, X3 inserts, 28 mm headOrthopaedic implant | Device | Trident cup, X3 inserts, 28 mm head |
| Trident cup, X3 inserts, 40 mm headOrthopaedic implant | Device | Trident cup, X3 inserts, 40 mm head |
| Symax stemOrthopaedic implant | Device | Trident cup, X3 inserts, 28 mm head, Trident cup, X3 inserts, 40 mm head |
| Accolade TMZF stemOrthopaedic implant | Device | Trident cup, X3 inserts, 28 mm head, Trident cup, X3 inserts, 40 mm head |
Primary outcome
To Compare Wear of the Polyethylene X3 Insert Based on Digital Radiographs Using the Hip Analysis Suite (HAS).
Time frame: 5 years follow-up
Determine equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes using HAS, a software for the determination of polyethylene wear on digital radiographs.
2 secondary outcomes
Harris Hip Score (HHS) Patient Questionnaire
Time frame: 6 weeks, 3 months, 1, 2 and 5 years
Merle D'Aubergine Score (MdA)
Time frame: 6 weeks, 3 months, 1, 2 and 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ide C. Heyligers, MD principal investigator
Atrium Medical Center, Heerlen, The Netherlands
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 cup, X3 inserts, 28 mm head, Trident cup, X3 inserts, 40 mm head and Symax stem in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 1 site in Netherlands.
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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 22 Feb 2024. 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 Netherlands. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Compare Wear of the Polyethylene X3 Insert Based on Digital Radiographs Using the Hip Analysis Suite (HAS). (time frame: 5 years follow-up). 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 22 Feb 2024.