Clinical Trial Finder

MDR - PMCF Study for Taperloc Complete Stems

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04028687
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries, Hip Pain Chronic
Additional Details

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

Arms & Interventions

Arms

: Taperloc Complete Stems

Patients that have been implanted with a Taperloc Complete Stem to repair hip malfunction/disease.

Interventions

Device: - Taperloc Complete Stem

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Orthopaedic Institute of Henderson, Henderson, Nevada

Status

Withdrawn

Address

Orthopaedic Institute of Henderson

Henderson, Nevada, 89052

Texas Health Physicians Group, Plano, Texas

Status

Recruiting

Address

Texas Health Physicians Group

Plano, Texas, 75243

Site Contact

Shuvie Dasgupta

[email protected]

972-981-7114

Bellevue, Washington

Status

Withdrawn

Address

Proliance Orthopaedics and Sports Medicine

Bellevue, Washington, 98004

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