Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

NCT02285842 | Active Not Recruiting

• 1 other identifier: 12-LJH-002F
• Study Type: observational
• Target: 143
• 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)

• 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

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

• Component alignment

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

Study Arms (1)

Primary Hip Resurfacings

Single study group previously implanted with CONSERVE® Press-Fit Femoral Components

Device: Primary hip resurfacing device

Interventions

Primary hip resurfacing device DEVICE

CONSERVE® Press-Fit Femoral Components

Primary Hip Resurfacings

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 CONSERVE® Press-Fit Femoral Components

You may qualify if:

• Has undergone primary hip resurfacing 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 resurfacing 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 have pending incarceration

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

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

• Paul Beaule, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 7, 2014
• Study Start: December 1, 2014
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 7, 2023

Record last verified: 2023-04

Locations

CA (1)