Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components

NCT02668211 | Withdrawn

• 1 other identifier: 14LJH002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Disease; Osteoarthritis

Keywords

osteoarthritis; radiostereometric analysis; correction of functional deformity; procedures; total hip arthroplasty; musculoskeletal diseases

Outcome Measures

Primary Outcomes (3)

• Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance.

  Assessment of the quantity of migration to determine if the total migration of the stem and cup at 2 years post¬operatively are less than 1.2 mm and 2.6mm, and also less than 0.4mm. Assessment of continuous migration to determine if continuous migration, defined as 0.2mm of motion between 1 and 2 years as measured with RSA exists in the stem and cup.

  24 months

• Determine the migration patterns of the PROFEMUR® Preserve Classic stem with RSA

  Assessment of migration in each individual plane (x, y, and z), as measured in mm.

  24 months

• Assess if migration pattern is greater than 0.2mm between 1 and 2 years

  To determine if the wear rate device is substantially less than the scientifically accepted threshold of 0.1 mm/year for osteolysis. The outcomes will be compared to data from the literature, which states that motion greater than 0.2mm between 1 and 2 years suggests an implant is at risk for early loosening.

  24 months

Secondary Outcomes (1)

• Patient functional outcomes (HOOS)

  24 months

Study Arms (1)

PROFEMUR Preserve RSA

OTHER

Single cohort of subjects prospectively implanted with PROFEMUR® Preserve Classic femoral components

Device: PROFEMUR Preserve Classic Femoral Components

Interventions

PROFEMUR Preserve Classic Femoral Components DEVICE

Also known as: Total Hip Arthroplasty System

PROFEMUR Preserve RSA

Eligibility Criteria

• Age: 21 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Arthritis; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: January 29, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

CA (1)