Hip ArthritisNCT04028687
MDR - PMCF Study for Taperloc Complete Stems
An observational study of Hip Arthritis and Hip Disease, run by Zimmer Biomet at 3 sites in United States.
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*. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthritis, Hip Disease, Hip Fractures
- What is being tested?
- Taperloc Complete Stem
- Type of treatment
- Medical device
- How many people
- 820 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Feb 2020to 12 Feb 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Off-label use
- Infection
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis
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- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Withdrawn
Proliance Orthopaedics and Sports Medicine
Bellevue, Washington, 98004
- Withdrawn
Orthopaedic Institute of Henderson
Henderson, Nevada, 89052
- Recruiting
Texas Health Physicians Group
Plano, Texas, 75243
Shuvie Dasgupta, 972-981-7114, shuvalaxmidasgupta@texashealth.org
Roger Emerson, MD
About this study
Official title: Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems
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.
Read the 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
- Conditions
- Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries, Hip Pain Chronic
- Being tested
- Taperloc Complete Stem
- Medical subject headings
- Hip Fractures, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taperloc Complete StemDevice
Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.
| Study group | Role | What they receive |
|---|---|---|
| Taperloc Complete Stems | Patients that have been implanted with a Taperloc Complete Stem to repair hip malfunction/disease. Receives: Device: Taperloc Complete Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Out to 10 Years
Secondary outcomes (2)
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.
Measured: Out to 10 Years
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.
Measured: Out to 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start13 Feb 2020
- Primary completion12 Feb 2032 (estimated)
- Study completion12 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028687
- Sponsor's protocol ID
- MDRG2017-89MS-39H
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2019
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No