Early Weight-Bearing After Lapidus Arthrodesis

Stopped early

Conditions studied: Arthrodesis, Bunion, Hallux Valgus

In brief

The goal of this research study is to determine if union rates are affected by early weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail. The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis procedure with the Phantom™ Intramedullary Nail and participate in an early weight-bearing protocol will be non-inferior to union rates previously published for this procedure.

Key facts

Study ID

NCT03257540

Run by

Paragon 28

People needed

8

Starts

2017-10-31

Expected to finish

2018-08-31

Last updated by the study team

2018-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is at least 18 years of age with closed physeal plates at the time of screening.
• The intermetatarsal angle is greater than or equal to 10 degrees.
• The hallux valgus angle is greater than or equal to 25 degrees.
• The subject has foot pain/discomfort on the foot in question.
• The subject has activity limitations due to the foot in question.
• The subject agrees to comply with the requirements of the study and complete the study measures.
• The subject is willing and able to provide written informed consent.

You may not qualify if…

• The subject is pregnant.
• The subject is a current smoker.
• The subject has been clinically diagnosed with diabetes.
• The subject has been clinically diagnosed with peripheral neuropathy.
• The subject had been previously sensitized to titanium.
• The subject currently takes oral steroids or rheumatoid biologics.
• The subject has had previous surgery for hallux valgus on operative side.
• The subject has insufficient quantity or quality of bone to permit stabilization, conditions that retard healing (not including pathological fractures) and conditions causing poor blood supply such as peripheral vascular disease.
• The subject has a history of delayed or non-union for fracture or joint.
• The subject has an active, suspected or latent infection in the affected area.
• The subject will require a structural graft in the 1st TMT joint.
• The subject is scheduled to undergo a concomitant 2nd tarsometatarsal joint arthrodesis procedure.
• The subject is scheduled to undergo a same-day bilateral procedure.
• The subject cannot be scheduled for surgery within 3 months of the pre-operative exam.
• The subject has previously been enrolled into this study for a contralateral procedure.
• The subject is actively involved with a Workman's Compensation case.
• The subject is not expected to complete the study according to the investigation plan.
• The subject has been deemed physiologically or psychologically inadequate by the enrolling physician.
• The subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, a known abuser of alcohol and/or drugs or anticipated to be non-compliant.

Where it is running

• Redwood Orthopaedic Surgery Associates — Santa Rosa, California, United States
• Orthopaedic & Spine Center of the Rockies — Fort Collins, Colorado, United States
• Orthopedic Center of Palm Beach County — Atlantis, Florida, United States

Full record on ClinicalTrials.gov

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