Hip ArthropathyNCT05734651
PROMIS Evaluation Study
An observational study of Hip Arthropathy and Osteoarthritis, Hip, run by Bezirkskrankenhaus St. Johann in Tirol at 1 site in Austria.
Trial summary
A total of 250 total hip arthroplasties (THA) are performed at the Bezirkskrankenhaus St. Johann. In a majority of those, implants from the company Falcon Medical (Austria) are used. Those implants are undergoing constant development and improvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy, Osteoarthritis, Hip, Perthes Disease
- What is being tested?
- PROMIS Stem
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 9 Feb 2023to 9 Feb 2042
- How long will I take part?
- 20 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient treated with primary total hip arthroplasty at this department are included.
Who may be able to join
- Primary total hip arthroplasty with the PROMIS stem
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
BKH St. Johann in Tirol, Department for Orthopedics and Traumatology
Sankt Johann in Tirol, Tyrol, 6380
Moritz Wagner, Dr. med. univ., +4367762930592, moritz.wagner@khsj.at
Alexander Brunner, Priv.-Doz. Dr. med. univ., +435352 6068780, alexander.brunner@khsj.at
About this study
Official title: Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty
A total of 250 total hip arthroplasties (THA) are performed at the Bezirkskrankenhaus St. Johann. In a majority of those, implants from the company Falcon Medical (Austria) are used. Those implants are undergoing constant development and improvement. To guarantee their clinical performance, this clinical study is evaluating safety and efficacy of all implants produced by Falcon Medical.
The purpose of this study is to evaluate the effcacy and safety of implants produced and distributed by Falcon Medical. All patients with primary THA and usage of a Falcon Medical implant are included. The outcome measures include intra-operative complications, early post-operative complications, revision for any cause and patient reported outcome (WOMAC questionnaire). All data is prospectively collected in a standardized fashion.
- Conditions
- Hip Arthropathy, Osteoarthritis, Hip, Perthes Disease, Osteonecrosis, Femoral Neck Fractures
- Being tested
- PROMIS Stem
- Medical subject headings
- Osteoarthritis, Hip, Legg-Calve-Perthes Disease, Osteonecrosis, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMIS StemDevice
Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Not described Receives: Device: PROMIS Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stem Migration
Stem Migration measured with the validated EBRA method. The stem migration is assessed in millimeters. The radiograph before surgery and sequential radiographs after surgery are assessed.
Measured: 20 years
Secondary outcomes (1)
WOMAC Score
Patient reported outcome score that is assessed before the surgery and one year after the surgery, 5 years after the surgery, 10 years and 20 years after the surgey.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start9 Feb 2023
- Primary completion9 Feb 2026 (estimated)
- Study completion9 Feb 2042 (estimated)
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 Hip ArthropathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Bezirkskrankenhaus St. Johann in Tirol
- Sponsor type
- University, hospital or other
- Collaborators
- Tyrolean Arthroplasty Registry
- Responsible party
- Principal investigator, Moritz Wagner, Bezirkskrankenhaus St. Johann in Tirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734651
- Sponsor's protocol ID
- 1297/2022
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Wagner M, Neururer S, Dammerer D, Nardelli P, Kaufmann G, Braito M, Brunner A. External validation of the Tyrolean hip arthroplasty registry. J Exp Orthop. 2022 Aug 30;9(1):87. doi: 10.1186/s40634-022-00526-3.
PubMed 36042064
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05734651
- Acronym / sponsor ID
- 1297/2022
- Conditions
- Hip Arthropathy, Osteoarthritis, Hip, Perthes Disease, Osteonecrosis, Femoral Neck Fractures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bezirkskrankenhaus St. Johann in TirolUniversity, hospital or other
- Collaborators
- Tyrolean Arthroplasty Registry
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 9 Feb 2026 (estimated)
- Study completion
- 9 Feb 2042 (estimated)
- First posted
- 21 Feb 2023 (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.
A total of 250 total hip arthroplasties (THA) are performed at the Bezirkskrankenhaus St. Johann. In a majority of those, implants from the company Falcon Medical (Austria) are used. Those implants are undergoing constant development and improvement. To guarantee their clinical performance, this clinical study is evaluating safety and efficacy of all implants produced by Falcon Medical.
The purpose of this study is to evaluate the effcacy and safety of implants produced and distributed by Falcon Medical. All patients with primary THA and usage of a Falcon Medical implant are included. The outcome measures include intra-operative complications, early post-operative complications, revision for any cause and patient reported outcome (WOMAC questionnaire). All data is prospectively collected in a standardized fashion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Device: PROMIS Stem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient treated with primary total hip arthroplasty at this department are included.
Key inclusion criteria (1 listed)
- Primary total hip arthroplasty with the PROMIS stem
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| PROMIS StemPrimary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria) | Device | Intervention |
Primary outcome
Stem Migration
Time frame: 20 years
Stem Migration measured with the validated EBRA method. The stem migration is assessed in millimeters. The radiograph before surgery and sequential radiographs after surgery are assessed.
1 secondary outcome
WOMAC Score
Time frame: 20 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 21 Feb 2023.
- Results publication: PubMed 36042064Wagner M, Neururer S, Dammerer D, Nardelli P, Kaufmann G, Braito M, Brunner A. External validation of the Tyrolean hip arthroplasty registry. J Exp Orthop. 2022 Aug 30;9(1):87. doi: 10.1186/s40634-022-00526-3.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthropathy and Osteoarthritis, Hip, run by Bezirkskrankenhaus St. Johann in Tirol at 1 site in Austria.
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: looking for participants now, as of the sponsor's last update on 21 Feb 2023. 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 Austria. 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?
Contact Moritz Wagner, MD (+4350536608167, moritz.wagner@khsj.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stem Migration (time frame: 20 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 NCT05734651, 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 21 Feb 2023.