Clinical trial NCT02668211: Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
Official title: Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Joint Disease
Osteoarthritis
Keywords: osteoarthritis
radiostereometric analysis
correction of functional deformity
procedures
total hip arthroplasty
musculoskeletal diseases
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone.


Eligibility criteria: Inclusion Criteria:

* Subject is a candidate for primary THA for osteoarthritis
* Subject is able to undergo primary THA procedure
* Subject is a candidate to be implanted with the specified combination of components
* Subject is willing and able to complete required study visits and assessments
* Subject is willing to sign the approved Informed Consent document

Exclusion Criteria:

* Subject has any of the following contraindications at the time of the implantation:
* Overt infection;
* Distant foci of infections (which may cause hematogenous spread to the implant site);
* Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram;
* Skeletally immature (less than 21 years of age at time of surgery);
* Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;
* Subjects 76 years of age or older
* Subjects with post-traumatic arthritis in the affected hip
* Subjects with rheumatoid arthritis in the affected hip
* Subjects with hip dysplasia in the affected hip
* Subjects with prior arthroplasty of the affected hip
* Subjects that are morbidly obese (BMI \> 35)
* Subjects that are immuno-suppressed
* Subjects with known or tested-positive allergy to metals
* Subjects currently enrolled in another clinical investigation which could affect the endpoints of this protocol
* Subjects unwilling or unable to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or have pending incarceration

Primary outcomes:
measure: Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance.
timeFrame: 24 months
measure: Determine the migration patterns of the PROFEMUR® Preserve Classic stem with RSA
timeFrame: 24 months
measure: Assess if migration pattern is greater than 0.2mm between 1 and 2 years
timeFrame: 24 months
Secondary outcomes:
measure: Patient functional outcomes (HOOS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hopital Maisonneuve Rosemont
state: Quebec
Study officials:
References: