Clinical trial NCT04028687: MDR - PMCF Study for Taperloc Complete Stems
Official title: Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Arthritis
Hip Disease
Hip Fractures
Hip Injuries
Hip Pain Chronic
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-07-23
Enrollment: 820
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A consecutive series of patients implanted with the Taperloc Complete Stems in primary or revision total hip arthroplasty according to the approved indications.

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

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
* Sepsis
* 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
* Patient is known to be pregnant or nursing
* Patient is a prisoner
* Patient is a known alcohol or drug abuser
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent

Primary outcomes:
measure: Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events.
timeFrame: Out to 10 Years
Secondary outcomes:
measure: Device Performance and Benefits evaluated through the Harris Hip Score
timeFrame: Out to 10 Years
measure: Device Performance and Benefits evaluated through the Oxford Hip Score
timeFrame: Out to 10 Years
Other outcomes:
Locations:
city: Henderson
country: United States
facility: Orthopaedic Institute of Henderson
state: Nevada
city: Plano
country: United States
facility: Texas Health Physicians Group
state: Texas
city: Bellevue
country: United States
facility: Proliance Orthopaedics and Sports Medicine
state: Washington
Study officials:
References: