Clinical trial NCT02314611: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems
Official title: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Joint Disease
Keywords: osteoarthritis
avascular necrosis
ankylosis
protrusio acetabuli
painful hip dysplasia
rheumatoid arthritis
correction of functional deformity
revision procedures
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 154
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been previously implanted with a PROFEMUR® Gladiator HA Coated Modular Femoral Stem

Brief summary: MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.


Eligibility criteria: Inclusion Criteria:

* Subject has undergone primary THA for any of the following:
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
* Inflammatory degenerative joint disease such as rheumatoid arthritis; or
* Correction of functional deformity
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Investigator Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.

Exclusion Criteria:

* Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated

Primary outcomes:
measure: Component Survivorship
timeFrame: 10 years post-operative
Secondary outcomes:
measure: Patient functional outcomes (hip specific)
timeFrame: 5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval
measure: Patient functional outcomes (quality of life)
timeFrame: 5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval
Other outcomes:
Locations:
city: Sint-Martens-Latem
country: Belgium
facility: Medisch Centrum Latem (outpatient clinic associated with AZ Maria-Middelares)
state: Flanders
Study officials:
affiliation: Algemeen Ziekenhuis Maria-Middelares (Gent, Belgium)
name: Philippe Van Overschelde, MD
role: PRINCIPAL_INVESTIGATOR
References: