PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

NCT02507258 | Withdrawn

• 1 other identifier: 12-LJH-002K
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Disease

Keywords

osteoarthritis; avascular necrosis; correction of functional deformity; painful hip dysplasia; protrusio acetabuli; rheumatoid arthritis; ankylosis

Outcome Measures

Primary Outcomes (1)

• Component Survivorship

  The primary objective of this study is to estimate survivorship using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. Measured by capturing date of revision or removal of the device.

  10 years post-operative

Secondary Outcomes (1)

• Patient functional outcomes (hip specific)

  Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval

Study Arms (1)

PROFEMUR® Am Femoral Stem

Single study group previously implanted with a primary PROFEMUR® Am Femoral Stem and PROCOTYL® O HA Coated Acetabular Component

Device: PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell

Interventions

PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell DEVICE

PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component

PROFEMUR® Am Femoral Stem

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been previously implanted with a PROFEMUR® Am Femoral Stem and PROCOTYL® O HA-Coated Acetabular Component

You may qualify if:

• 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

You may not qualify if:

• Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
• Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA
• 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 having pending incarceration

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

Hopital Joseph Ducuing

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid; Ankylosis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gérard Giordano, MD

  Hopital Joseph Ducuing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 23, 2015
• Study Start: December 1, 2017
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 7, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)