Post Market Clinical Follow-up Study Protocol for PROFEMUR® Xm Femoral Stems

NCT02309593 | Terminated

• 1 other identifier: 12-LJH-002A
• Study Type: observational
• Target: 52
• 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; ankylosis; protrusio acetabuli; painful hip dysplasia; rheumatoid arthritis; correction of functional deformity; revision procedures

Outcome Measures

Primary Outcomes (1)

• Component Survivorship

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

  10 years post-operative

Secondary Outcomes (2)

• Patient functional outcomes (hip specific)

  Previously implanted subjects: 6 months, 1, 3, 5, 7, and 10 years postoperatively beginning with first available visit; not previously implanted subjects: Pre-operative, 6 months, 1, 3, 5, 7, and 10 years postoperatively.

• Patient functional outcomes (quality of life)

  Previously implanted subjects: 6 months, 1, 3, 5, 7, and 10 years postoperatively beginning with first available visit; not previously implanted subjects: Pre-operative, 6 months, 1, 3, 5, 7, and 10 years postoperatively.

Study Arms (1)

PROFEMUR® Xm Femoral Stems

Single study group either previously implanted or will be implanted with the following combination of components: PROFEMUR® Xm Femoral Stems, with any type of Acetabular Shells.

Device: PROFEMUR® Xm Femoral Stems

Interventions

PROFEMUR® Xm Femoral Stems DEVICE

THA using PROFEMUR® Xm Femoral Stems

Also known as: Primary hip replacement device

PROFEMUR® Xm 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

Single study group either previously implanted or will be implanted with the following combination of components: PROFEMUR® Xm Femoral Stems, with any type of Acetabular Shells.

You may qualify if:

• Subject previously underwent / is a candidate for 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 has been previously implanted / is a candidate to be implanted with the specified combination of components
• Subject is willing and able to complete required study visits or assessments
• Not previously implanted subject is able to undergo primary THA procedure
• 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
• Prospective enrollment of a previously unimplanted contralateral hip is permitted in this study provided:
• it occurs not more than two years after the index THA
• the specified combination of components is used
• 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
• Subject is skeletally immature (less than 21 years of age) at time of primary THA surgery
• Subject is currently enrolled in another clinical study which could affect the endpoints of this protocol
• Subject is unwilling to sign the Informed Consent document
• Subject has substance abuse issues
• Subject is incarcerated or has pending incarceration
• Subject is anticipated to require a contralateral THA less than 1 year after the index THA on the enrolled hip
• In addition, not previously implanted subjects will be excluded if they meet any of the following criteria:
• Subject has any of the following contraindications at the time of implantation

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

St. Marien-Hospital Mülheim, Klinik für Orthopädie, Unfall & Wiederherstellungschirurgie

Mülheim, 45468, 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

• Marcus Jäger, MD

  St. Marien-Hospital Mülheim

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: December 1, 2014
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)