NCT02239783

Brief Summary

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
30mo left

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Nov 2014Nov 2028

First Submitted

Initial submission to the registry

September 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

13 years

First QC Date

September 11, 2014

Last Update Submit

November 16, 2023

Conditions

Joint Disease

Keywords

osteoarthritisavascular necrosisankylosisprotrusio acetabulipainful hip dysplasiarheumatoid arthritiscorrection of functional deformityrevision procedures

Outcome Measures

Primary Outcomes (1)

  • Component Survivorship

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

    10 years post-operative

Secondary Outcomes (1)

  • Patient functional outcomes

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

Study Arms (1)

Total Hip Arthroplasty

Single group previously implanted with the following combination of components: PROFEMUR® TL modular femoral stem, MicroPort Orthopedics acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head.

Device: total hip arthroplasty implant

Interventions

total hip arthroplasty implantDEVICE
Also known as: PROFEMUR® TL modular femoral stem
Total Hip Arthroplasty

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been previously implanted with a primary PROFEMUR® TL Modular Femoral Stem

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

You may not qualify if:

  • Subjects implanted with DYNASTY® BIOFOAM® Acetabular Shells
  • Subjects implanted with a metal-on-metal articulation
  • Subjects implanted with non-MicroPort Orthopedics components (femoral heads, acetabular shells, acetabular liners) 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 have pending incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H-8L6, Canada

Location

MeSH Terms

Conditions

Joint DiseasesOsteoarthritisOsteonecrosisAnkylosisArthritis, Rheumatoid

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesArthritisRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

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

September 11, 2014

First Posted

September 15, 2014

Study Start

November 1, 2014

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

CA(1)