Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

NCT02314702 | Active Not Recruiting

• 1 other identifier: 12-LJH-002L
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the 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 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)

• Number of participants who require a revision

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

  10 years post-operative

Secondary Outcomes (2)

• Patient functional score on the the Oxford Hip Score instrument

  Screening (First Available), 2-5 years, 5-7 years, and 10 years

• Patient functional score on the EQ-5D-3L instrument

  Screening (First Available), 2-5 years, 5-7 years, and 10 years

Study Arms (1)

Revision Total Hip Arthroplasty

Single study group previously implanted with a PROFEMUR® L Revision Femoral Stem

Device: PROFEMUR® L Revision Femoral Stem

Interventions

PROFEMUR® L Revision Femoral Stem DEVICE

Revision Total Hip Arthroplasty

Also known as: Hip Revision Device

Revision Total Hip Arthroplasty

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 PROFEMUR® L Revision Femoral Components

You may qualify if:

• Has undergone revision total hip arthroplasty
• 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 currently enrolled in another clinical study
• Subjects unwilling to sign the Informed Consent document
• Subjects with substance abuse issues
• Subjects who are incarcerated or have pending incarceration

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

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 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 11, 2014
• Study Start: September 4, 2015
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)