MDR - PMCF Study for Taperloc Complete Stems

Hip Fractures Clinical Trial

Official title:

Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028687
• Other study ID #: MDRG2017-89MS-39H
• Status: Recruiting
• Start date: February 13, 2020
• Est. completion date: February 12, 2032

Study information

• Verified date: December 2023
• Source: Zimmer Biomet
• Contact: Abigail Fishel
• Phone: 574-526-1765
• Email: Abigail.Fishel[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 820
• Est. completion date: February 12, 2032
• Est. primary completion date: February 12, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthritis
• Hip Disease
• Hip Fractures
• Hip Injuries
• Hip Pain Chronic

Intervention

Device:
• Taperloc Complete Stem
Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.

Locations

Country	Name	City	State
United States	Proliance Orthopaedics and Sports Medicine	Bellevue	Washington
United States	Orthopaedic Institute of Henderson	Henderson	Nevada
United States	Texas Health Physicians Group	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events.	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.	Out to 10 Years
Secondary	Device Performance and Benefits evaluated through the Harris Hip Score	The HHS is divided into 4 sub-categories; pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). Patients select a discrete set of answers which correspond to predefined point allocations based on the category. To obtain a final score, these values are summed.	Out to 10 Years
Secondary	Device Performance and Benefits evaluated through the Oxford Hip Score	The OHS is a patient-completed, 12-question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms.	Out to 10 Years