MAC-STILA: a feasibility test for hip fracture surgery anesthesia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional feasibility study examines MAC-STILA, an anesthesia approach using monitored anesthesia care and local anesthetic footed by soft tissue infiltration, during hip fracture surgeries. It will compare outcomes with and without cognitive impairment to explore effects on delirium and other secondary outcomes. Eligible participants are adults 65+ undergoing intertrochanteric or femoral neck fracture repair by various fixation methods. Exclusion criteria include pre-operative delirium, malignant hyperthermia risk, and severe dementia, among others. The study is led by NYU Langone Health with NIA collaboration and involves sites in Evanston, Baltimore, and New York.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\- Adults aged 65 years and older undergoing surgical repair for an intertrochanteric or femoral neck hip fracture are eligible for the study. Fracture fixation can be with cannulated screws, a sliding hip screw (or similar device), a short cephalomedullary nail, or a long cephalomedullary nail.

Exclusion Criteria:

* Patients with pre-operative delirium;
* Patients with a periprosthetic or peri implant fracture;
* Patients at risk for malignant hyperthermia (history of malignant hyperthermia, family history of malignant hyperthermia susceptibility, history of rhabdomyolysis);
* Patients with contraindication to local anesthesia;
* considered unsuitable for randomization by the surgeon or anesthesiologist on the basis of the physician's clinical assessment (e.g. severe pulmonary disease);
* treated with hip arthroplasty
* received a preoperative peripheral nerve block; or
* severe dementia defined as pre-operative MMSE score \< 15.

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting
• Northshore (Endeavor Health)
  Evanston, Illinois, United States Not yet recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Not yet recruiting
• Jamaica Hospital
  Queens, New York, United States Not yet recruiting
• University of Utah
  Salt Lake City, Utah, United States Not yet recruiting

Study contacts

• Principal investigator: Sanjit Konda, MD — NYU Langone Health
• Study coordinator: Shifa Ahmed
• Email: shifa.ahmed@nyulangone.org
• Phone: 774-217-2467

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.