Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented HipprosthesisPhase 4NCT01695213
RCT Comparing the DEXA Results of the HA-Omnifit Versus the Symax Uncemented Hip Stem
A Phase 4 study testing uncemented total hip arthroplasty in people with Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis, run by Maastricht University Medical Center.
Trial summary
Thr purpose of this study is to compare the clinical and radiological results, as well as the femur bone density measurements of two uncemented total hip prostheses during 5 years of follow up. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis
- What is being tested?
- uncemented total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Jul 2009
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- chronic anti-inflammatory medication use> 3 months
- revision surgery to the affected femur
- Cancer therapy including immunosuppression, chemotherapy and radiation
- Pathological fractures, delayed ossification or non-union is likely to occur
About this study
Official title: A Randomized Comparative Study to Evaluate the Performance and Confirm the Safety of the Diocom Hip Syhstem in Cementless Hip Arthroplasty
Thr purpose of this study is to compare the clinical and radiological results, as well as the femur bone density measurements of two uncemented total hip prostheses during 5 years of follow up.
Read the detailed description
It is of great importance for the function of uncemented total hip arthroplasty that the anchorage of the prosthesis in the bone of the femur is sufficient. This is of great importance in the prevention of stress shielding of the bone and to insure tranfer of forces from the prosthesis to the femur.
The symax hip stem is developed to optimize stress tranfer to bone and insure mechanical stability.
In this study the symax hip stem is compared to the HA_Omnifit hip stem (a frequently used and long term evaluated uncemented hip prosthesis) During the fist two years of follow up DEXA mesurments of bone mineral density are performed. Also patient satisfaction, patient fuction score and radiological evaluation measurements are done during 5 years of follow up.
Our primary objective is: comparison of the short term bone remodelling surrounding the Symax hip stem to the short term remodeling surrounding the Stryker Omnifit HA hip stem measured by bone densitometry, clinical and radiographic evaluation.
- Being tested
- uncemented total hip arthroplasty
- Keywords
- uncemented hip, bone remodeling, DEXA, clinical evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uncemented total hip arthroplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HA-Omnifit | Active comparator | Patients who receive a HA-Omnifit uncemented hip stem Receives: Procedure: uncemented total hip arthroplasty |
| Symax hip stem | Active comparator | Patients with the Symax uncemented hip stem Receives: Procedure: uncemented total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
short term bone remodeling
Bone remodeling is determined by measuring the Bone mineral density during time
Measured: 6 times within 2 years
complications and reoperations
Reporting all complications and reoperations of the two different hip prostheses
Measured: during 5 years
Secondary outcomes (2)
clinical performance
Comparison of the clinical performance of the two different hip prostheses
Measured: 9 times within 5 years
Radiological evaluation
Evaluation of Xrays according to the engh classifications
Measured: 9 times within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startApr 2003
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented HipprosthesisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Lodewijk van Rhijn, Study director, azM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695213
- Sponsor's protocol ID
- Symax DEXA study
- Other IDs
- MEC 02-072
- Status last verified
- Sep 2012
- First submitted
- 25 Sep 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
ten Broeke RH, Tarala M, Arts JJ, Janssen DW, Verdonschot N, Geesink RG. Improving peri-prosthetic bone adaptation around cementless hip stems: a clinical and finite element study. Med Eng Phys. 2014 Mar;36(3):345-53. doi: 10.1016/j.medengphy.2013.12.006. Epub 2013 Dec 27.
PubMed 24378381
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study to Evaluate the Performance and Confirm the Safety of the Diocom Hip Syhstem in Cementless Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01695213
- Acronym / sponsor ID
- Symax DEXA study
- Keywords
- uncemented hip, bone remodeling, DEXA, clinical evaluation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Apr 2003
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Sep 2012 (estimated)
- 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.
Thr purpose of this study is to compare the clinical and radiological results, as well as the femur bone density measurements of two uncemented total hip prostheses during 5 years of follow up.
Detailed description
It is of great importance for the function of uncemented total hip arthroplasty that the anchorage of the prosthesis in the bone of the femur is sufficient. This is of great importance in the prevention of stress shielding of the bone and to insure tranfer of forces from the prosthesis to the femur.
The symax hip stem is developed to optimize stress tranfer to bone and insure mechanical stability.
In this study the symax hip stem is compared to the HA_Omnifit hip stem (a frequently used and long term evaluated uncemented hip prosthesis) During the fist two years of follow up DEXA mesurments of bone mineral density are performed. Also patient satisfaction, patient fuction score and radiological evaluation measurements are done during 5 years of follow up.
Our primary objective is: comparison of the short term bone remodelling surrounding the Symax hip stem to the short term remodeling surrounding the Stryker Omnifit HA hip stem measured by bone densitometry, clinical and radiographic evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA-Omnifit | Active comparator | Procedure: uncemented total hip arthroplastyPatients who receive a HA-Omnifit uncemented hip stem |
| Symax hip stem | Active comparator | Procedure: uncemented total hip arthroplastyPatients with the Symax uncemented hip stem |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- chronic anti-inflammatory medication use> 3 months
- revision surgery to the affected femur
- Cancer therapy including immunosuppression, chemotherapy and radiation
- Pathological fractures, delayed ossification or non-union is likely to occur
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 |
|---|---|---|
| uncemented total hip arthroplasty | Procedure or surgery | HA-Omnifit, Symax hip stem |
Primary outcome
short term bone remodeling
Time frame: 6 times within 2 years
Bone remodeling is determined by measuring the Bone mineral density during time
complications and reoperations
Time frame: during 5 years
Reporting all complications and reoperations of the two different hip prostheses
2 secondary outcomes
clinical performance
Time frame: 9 times within 5 years
Radiological evaluation
Time frame: 9 times within 5 years
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 27 Sep 2012.
- Derived from this study: PubMed 24378381ten Broeke RH, Tarala M, Arts JJ, Janssen DW, Verdonschot N, Geesink RG. Improving peri-prosthetic bone adaptation around cementless hip stems: a clinical and finite element study. Med Eng Phys. 2014 Mar;36(3):345-53. doi: 10.1016/j.medengphy.2013.12.006. Epub 2013 Dec 27.
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.
Lodewijk van Rhijn study director
azM
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing uncemented total hip arthroplasty in people with Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis, 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 0 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: finished, as of the sponsor's last update on 27 Sep 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
short term bone remodeling (time frame: 6 times within 2 years). The study lists 2 primary outcomes in all. 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 NCT01695213, which also lists 1 linked publication.
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 27 Sep 2012.