Hip OsteoarthritisNCT03469687
Symax International Study
A study testing Symax uncemented hip stem in people with Hip Osteoarthritis and Prosthesis Durability, run by Maastricht University Medical Center.
Trial summary
The uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip stem. The Symax stem design combines an anatomical anteverted proximal geometry with a straight distal section. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hip Osteoarthritis, Prosthesis Durability
- What is being tested?
- Symax uncemented hip stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2004to 11 Oct 2010
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring uncemented primary total hip arthroplasty (osteoarthritis, avascular necrosis and/or post-traumatic arthritis), age between 18-70 years, BMI less or equal to 35.
Who cannot join
- Patients with bilateral hip complaints, impaired cognitive function and use of medication or illness influencing bone metabolism.
About this study
Official title: 5 Year Clinical and Radiographic Follow-up of the Uncemented Symax Hip Stem in an International Study
The uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip stem. The Symax stem design combines an anatomical anteverted proximal geometry with a straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA) coating for improved osseointegration to enhance load transfer and to minimize proximal bone loss. The distal part is treated with an anodization surface treatment in order to prevent distal bone apposition, which is expected to prevent distal loading and reduce proximal stress shielding. Aim of this study is to report mid-term clinical performance and evaluate whether the radiographic features are in line with the design principles of the Symax hip in an international clinical study with 5 years of follow-up.
- Conditions
- Hip Osteoarthritis, Prosthesis Durability
- Being tested
- Symax uncemented hip stem
- Medical subject headings
- Osteoarthritis, Hip, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symax uncemented hip stemDevice
| Study group | Role | What they receive |
|---|---|---|
| Symax uncemented hip stem | Other | The Symax hip stem is an uncemented design forged from Ti6Al4V alloy (Stryker EMEA). Primary mechanical stability is provided by anatomical metaphyseal geometry. The hip stem features a size dependent anteversion, neck length and offset, with a CCD angle of 128°. Secondary biological stability is accomplished by fast osseous integration due to the BONIT-HA coating on the metaphyseal part of the stem. Receives: Device: Symax uncemented hip stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Harris Hip Score (HHS) during follow-up
A hip specific functional score
Measured: Preoperative HHS and postoperatively change in HHS at 6 months, 1 year, 2 years, 3 years and 5 years
Secondary outcomes (1)
Radiographic evaluations
Radiographic evaluations per Gruen zone and comparison between two assessment teams
Measured: Immediately postoperative radiograhpic evaluation as baseline and changes in radiography at follow-up 6 months, 1 year, 2 years, 3 years and 5 years we evaluated the radiograhip evaluations again
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start2 Nov 2004
- Primary completion11 Oct 2010
- Study completion11 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital, Stryker Orthopaedics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469687
- Sponsor's protocol ID
- METC 04-112
- Status last verified
- Jan 2018
- First submitted
- 15 Jan 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ten Broeke RH, Hendrickx RP, Leffers P, Jutten LM, Geesink RG. Randomised trial comparing bone remodelling around two uncemented stems using modified Gruen zones. Hip Int. 2012 Jan-Feb;22(1):41-9. doi: 10.5301/HIP.2012.9103.
PubMed 22383318ten Broeke RH, Alves A, Baumann A, Arts JJ, Geesink RG. Bone reaction to a biomimetic third-generation hydroxyapatite coating and new surface treatment for the Symax hip stem. J Bone Joint Surg Br. 2011 Jun;93(6):760-8. doi: 10.1302/0301-620X.93B6.24986.
PubMed 21586774Kruijntjens DSMG, Kjaersgaard-Andersen P, Revald P, Leonhardt JS, Arts JJC, Ten Broeke RHM. 5-year clinical and radiographic follow-up of the uncemented Symax hip stem in an international study. J Orthop Surg Res. 2018 Jul 31;13(1):191. doi: 10.1186/s13018-018-0888-9.
PubMed 30064453
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5 Year Clinical and Radiographic Follow-up of the Uncemented Symax Hip Stem in an International Study
- ClinicalTrials.gov ID
- NCT03469687
- Acronym / sponsor ID
- METC 04-112
- Conditions
- Hip Osteoarthritis, Prosthesis Durability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Vejle Hospital, Stryker Orthopaedics
- Study start
- 2 Nov 2004 (actual)
- Primary completion
- 11 Oct 2010 (actual)
- Study completion
- 11 Oct 2010 (actual)
- First posted
- 19 Mar 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 uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip stem. The Symax stem design combines an anatomical anteverted proximal geometry with a straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA) coating for improved osseointegration to enhance load transfer and to minimize proximal bone loss. The distal part is treated with an anodization surface treatment in order to prevent distal bone apposition, which is expected to prevent distal loading and reduce proximal stress shielding. Aim of this study is to report mid-term clinical performance and evaluate whether the radiographic features are in line with the design principles of the Symax hip in an international clinical study with 5 years of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symax uncemented hip stem | Other | Device: Symax uncemented hip stemThe Symax hip stem is an uncemented design forged from Ti6Al4V alloy (Stryker EMEA). Primary mechanical stability is provided by anatomical metaphyseal geometry. The hip stem features a size dependent anteversion, neck length and offset, with a CCD angle of 128°. Secondary biological stability is accomplished by fast osseous integration due to the BONIT-HA coating on the metaphyseal part of the stem. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring uncemented primary total hip arthroplasty (osteoarthritis, avascular necrosis and/or post-traumatic arthritis), age between 18-70 years, BMI less or equal to 35.
Key exclusion criteria (1 listed)
- Patients with bilateral hip complaints, impaired cognitive function and use of medication or illness influencing bone metabolism.
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 |
|---|---|---|
| Symax uncemented hip stem | Device | Symax uncemented hip stem |
Primary outcome
Change of Harris Hip Score (HHS) during follow-up
Time frame: Preoperative HHS and postoperatively change in HHS at 6 months, 1 year, 2 years, 3 years and 5 years
A hip specific functional score
1 secondary outcome
Radiographic evaluations
Time frame: Immediately postoperative radiograhpic evaluation as baseline and changes in radiography at follow-up 6 months, 1 year, 2 years, 3 years and 5 years we evaluated the radiograhip evaluations again
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Results publication: PubMed 22383318ten Broeke RH, Hendrickx RP, Leffers P, Jutten LM, Geesink RG. Randomised trial comparing bone remodelling around two uncemented stems using modified Gruen zones. Hip Int. 2012 Jan-Feb;22(1):41-9. doi: 10.5301/HIP.2012.9103.
- Results publication: PubMed 21586774ten Broeke RH, Alves A, Baumann A, Arts JJ, Geesink RG. Bone reaction to a biomimetic third-generation hydroxyapatite coating and new surface treatment for the Symax hip stem. J Bone Joint Surg Br. 2011 Jun;93(6):760-8. doi: 10.1302/0301-620X.93B6.24986.
- Derived from this study: PubMed 30064453Kruijntjens DSMG, Kjaersgaard-Andersen P, Revald P, Leonhardt JS, Arts JJC, Ten Broeke RHM. 5-year clinical and radiographic follow-up of the uncemented Symax hip stem in an international study. J Orthop Surg Res. 2018 Jul 31;13(1):191. doi: 10.1186/s13018-018-0888-9.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Symax uncemented hip stem in people with Hip Osteoarthritis and Prosthesis Durability, run by Maastricht University Medical Center.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of Harris Hip Score (HHS) during follow-up (time frame: Preoperative HHS and postoperatively change in HHS at 6 months, 1 year, 2 years, 3 years and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469687, which also lists 3 linked publications.
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 19 Mar 2018.