Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Arthritis
- Sponsor
- Zimmer Biomet
- Enrollment
- 820
- Locations
- 3
- Primary Endpoint
- Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events.
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.
Detailed Description
The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point. The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified. The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs). \*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient must be 18 years of age or older and skeletally mature
- •Patient must be willing and able to sign IRB approved informed consent
- •Patient must have undergone primary or revision hip arthroplasty with the -Taperloc Complete stem according to a cleared indication, which includes the following:
- •Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- •Rheumatoid arthritis
- •Correction of functional deformity
- •Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
Exclusion Criteria
- •Off-label use
- •Infection
- •Osteomyelitis
- •Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- •Osteoporosis
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Distant foci of infections which may spread to the implant site
- •Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- •Vascular insufficiency, muscular atrophy, or neuromuscular disease
Outcomes
Primary Outcomes
Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events.
Time Frame: Out to 10 Years
The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to either implant or instrumentation should be specified.
Secondary Outcomes
- Device Performance and Benefits evaluated through the Oxford Hip Score(Out to 10 Years)
- Device Performance and Benefits evaluated through the Harris Hip Score(Out to 10 Years)