Recruiting

Taperloc Complete Stems

Sponsor:

Zimmer Biomet

Code:

NCT04028687

Conditions

Hip Arthritis

Hip Disease

Hip Fractures

Hip Injuries

Hip Pain Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Taperloc Complete Stem

Study Details

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.

Conditions

Hip Arthritis

Hip Disease

Hip Fractures

Hip Injuries

Hip Pain Chronic

Study ID

NCT04028687

Start date

Feb 13, 2020

Status verified date

Mar, 2025

Completion date

Feb 12, 2032

Anticipated

Primary completion date

Feb 12, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

820 participants

Anticipated

Interventions and Outcome Measures

Arms

Taperloc Complete Stems

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

Interventions

Taperloc Complete Stem

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

Primary outcome measure

  • Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events. [ Time Frame: Out to 10 Years ]

Central Contacts and Locations

Central contacts

Megan McKinnie

+1 (919) 381-7091megan.mckinnie@zimmerbiomet.com

Lynsey Boyle

+1 (412) 552-7111Lynsey.Boyle@zimmerbiomet.com

Locations

Texas Health Physicians Group

Recruiting

Plano, Texas, United States, 75243

Contacts

Shuvie Dasgupta

972-981-7114shuvalaxmidasgupta@texashealth.org

Principal Investigator:

Roger Emerson, MD

More Information

Sponsor

Zimmer Biomet

Last update posted

Mar 11, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zimmer Biomet on 2025-03-11.