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Device

Stryker© ADAPT™ platform for Hip Fracture

N/A

Recruiting

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Patients aged 18 years and older with isolated closed peritrochanteric femur fractures who are candidates for surgical fixation with a cephalomedullary nail device

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 1 year, and 2 years after surgery

Awards & highlights

Study Summary

This trial will test whether a new augmented reality platform can help surgeons place a screw in the skull during surgery.

Who is the study for?

This trial is for adults 18 and older with a specific type of hip fracture (peritrochanteric femur fractures) that hasn't broken through the skin. They should be suitable for surgery using a nail device to fix the bone.Check my eligibility

What is being tested?

The study is testing if an augmented-reality platform called Stryker© ADAPT™ can help surgeons better place the screw in a hip fracture repair procedure, compared to traditional methods using fluoroscopy.See study design

What are the potential side effects?

Potential side effects are not specified for this trial but may include typical surgical risks such as infection, pain at the site of surgery, bleeding, or complications from hardware placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 1 year, and 2 years after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 1 year, and 2 years after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 1 year, and 2 years after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tip-apex distance (TAD)

Secondary outcome measures

Evidence of lag screw cut-out

Fluoroscopy time

Hip range of motion

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Stryker© ADAPT™ platformExperimental Treatment1 Intervention

Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™platform to assist with insertion of the lag screw.

Group II: Traditional fluoroscopyActive Control1 Intervention

Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,447,199 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings currently available to join the trial?

"The clinical trial is recruiting as listed on the publicly available data hosted by clinicaltrials.gov, with an initial posting date of January 1st 2021 and most recent amendment dated March 16th 2022."

Answered by AI

How many individuals have registered to participate in this clinical research?

"Affirmative. According to clinicaltrials.gov, this research project is actively enrolling participants since its original posting on January 1st 2021 and the latest update being March 16th 2022. 60 people are needed between a single medical center for this trial."

Answered by AI

Recent research and studies

InjuryJournal

Optimising the Tip-apex-distance in Trochanteric Femoral Fracture Fixation Using the Adapt-navigated Technique, a Longitudinal Matched Cohort Study

Herzog, Jan, Robert Wendlandt, Sebastian Hillbricht, Rainer Burgkart, and Arndt-Peter Schulz. 2019. “Optimising the Tip-apex-distance in Trochanteric Femoral Fracture Fixation Using the Adapt-navigated Technique, a Longitudinal Matched Cohort Study”. Injury. Elsevier BV. doi:10.1016/j.injury.2019.02.010.

Seminars in Musculoskeletal RadiologyJournal

Hip and Femur Trauma

Yu, Joseph S.. 2000. “Hip and Femur Trauma”. Seminars in Musculoskeletal Radiology. Georg Thieme Verlag KG. doi:10.1055/s-2000-13013.

clinicaltrials.govStudy

Computer-Assisted Fixation of Trochanteric Femur Fractures

Wakenda K. Tyler, MD, MPH 2021. "Computer-Assisted Fixation of Trochanteric Femur Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04528459.