An interventional study of Monitored Anesthesia Care (MAC) and Soft Tissue Infiltration with Local Anesthetic (STILA) in Hip Fracture Surgeries, Intertrochanteric Fracture and Femoral Hip Fracture, sponsored by NYU Langone Health. Recruiting at 5 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
The purpose of this study is to establish preliminary efficacy of Monitored Anesthesia Care and Soft Tissue Infiltration with Local Anesthesia (MAC-STILA) on severity of post operative delirium and secondary outcomes in patients with and without cognitive impairment.
842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.
This study's planned enrollment of 140 is above the median of 86 across 533 interventional studies indexed under Hip Fractures.
Browse Hip Fractures studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive monitored anesthesia care with soft-tissue infiltration with local anesthesia (MAC-STILA) during surgery.
Procedure: Monitored Anesthesia Care (MAC) · Procedure: Soft Tissue Infiltration with Local Anesthetic (STILA)
Participants will receive general anesthesia during surgery.
Procedure: General Anesthesia
Anesthesiologist titration of intravenous sedation to a level that preserves a natural airway with spontaneous breathing.
Local anesthetic injected directly into the surgical site following sedation.
Participants will be sedated per general anesthesia procedures.
Enrollment Rate
Time frame: End-of-study (up to 90 days)
Percentage of completeness of data collected
Time frame: End-of-study (up to 90 days)
3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) score
The 3D-CAM also produces a delirium severity score which ranges from 0 to 20 (higher scores indicate higher delirium severity).
Time frame: Discharge from hospital (up to 5 days postoperative)
Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: shifa.ahmed@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to shifa.ahmed@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Dec 2027, 13 months after the start.
Of 221 non-industry interventional studies with no phase under Hip Fractures, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 55. This study's planned 13 months is below that.
Counting every sponsor, half of 237 studies reached it within 29 months; a quarter within 10 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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