Clinical trial NCT02239783: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems
Official title: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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: 2014-09-15
Enrollment: 143
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 primary PROFEMUR® TL Modular Femoral Stem

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

Detailed description: Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Subjects implanted with DYNASTY® BIOFOAM® Acetabular Shells
* Subjects implanted with a metal-on-metal articulation
* Subjects implanted with non-MicroPort Orthopedics components (femoral heads, acetabular shells, acetabular liners) in the enrolled THA
* 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 or have pending incarceration

Primary outcomes:
measure: Component Survivorship
timeFrame: 10 years post-operative
Secondary outcomes:
measure: Patient functional outcomes
timeFrame: Screening (First Available), 2-5 years, 5-7 years, and 10 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Paul Beaule, MD
role: PRINCIPAL_INVESTIGATOR
References: