Health TrialsbyHealthPanel

PROMIS Evaluation Study

ConditionsHip ArthropathyOsteoarthritis, HipPerthes DiseaseOsteonecrosisFemoral Neck Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBezirkskrankenhaus St. Johann in Tirol

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary total hip arthroplasty with the PROMIS stem

Disqualifiers

n/a

Trial population

Patient treated with primary total hip arthroplasty at this department are included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PROMIS Stem

    Device

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Intervention1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
20 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bezirkskrankenhaus St. Johann in Tirol

Lead sponsor

Tyrolean Arthroplasty Registry

Collaborator

Source ClinicalTrials.gov
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