PROMIS Evaluation Study

NCT ID: NCT05734651

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-09

Study Completion Date

2042-02-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Arthropathy Osteoarthritis, Hip Perthes Disease Osteonecrosis Femoral Neck Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

PROMIS Stem

Intervention Type DEVICE

Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PROMIS Stem

Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Primary total hip arthroplasty with the PROMIS stem

Exclusion Criteria

* n/a
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tyrolean Arthroplasty Registry

UNKNOWN

Sponsor Role collaborator

Bezirkskrankenhaus St. Johann in Tirol

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Moritz Wagner

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

BKH St. Johann in Tirol, Department for Orthopedics and Traumatology

Sankt Johann in Tirol, Tyrol, Austria

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Moritz Wagner, MD

Role: CONTACT

+4350536608167

Hannes Schönthaler, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Moritz Wagner, Dr. med. univ.

Role: primary

+4367762930592

Alexander Brunner, Priv.-Doz. Dr. med. univ.

Role: backup

+435352 6068780

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 36042064 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1297/2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exception Cementless Hip Stem
NCT04349046 ACTIVE_NOT_RECRUITING
AMIStem-H Radiographic Analysis
NCT02829866 COMPLETED
PMCF 8 Year Results TRJ®
NCT04542174 COMPLETED
Hip Prospective Study
NCT05956236 RECRUITING