PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

NCT02823834 | Active Not Recruiting

• 1 other identifier: 12-LJH-002H
• Study Type: observational
• Target: 121
• 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) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA 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; ankylosis; protrusio acetabuli; painful hip dysplasia; rheumatoid arthritis; correction of functional deformity

Outcome Measures

Primary Outcomes (1)

• Component Survivorship

  The primary objective of this study is to estimate survivorship analysis of all components at specified intervals out to 10 years follow-up.

  10 years post-operative

Secondary Outcomes (2)

• Patient functional outcomes (hip specific)

  2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit

• Patient functional outcomes (quality of life)

  2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit

Study Arms (1)

PROFEMUR® Gladiator Plasma Femoral Stems

Single study group either previously implanted with the following combination of components: PROFEMUR® Gladiator Plasma Femoral Stems, PROCOTYL® L Beaded Acetabular Shells, Polyethylene or Ceramic Liners, and Metal or Ceramic Femoral Heads.

Device: PROFEMUR® Gladiator Plasma Femoral Stems

Interventions

PROFEMUR® Gladiator Plasma Femoral Stems DEVICE

THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components

Also known as: Primary hip replacement device

PROFEMUR® Gladiator Plasma Femoral Stems

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® Gladiator Plasma Femoral Stem and PROCOTYL® L Beaded Acetabular Component

You may qualify if:

• 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:
• the specified combination of components were implanted in both

You may not qualify if:

• enrollment does not exceed the subject count specified in the Clinical Trial Agreement
• the subject agrees to a second Informed Consent document specific to the second THA.
• Subjects implanted with a metal-on-metal articulation
• Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) at the time of their primary THA 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 having pending incarceration

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

Elbe Kliniken Buxtehude

Buxtehude, 21614, Germany

Location

MeSH Terms

Conditions

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

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

• Jose Pimienta

  Elbe Kliniken Buxtehude

  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 1, 2016
• First Posted: July 6, 2016
• Study Start: June 16, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)