Hip Fracture SurgeriesMAC-STILANCT07897656
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
A study testing Monitored Anesthesia Care (MAC), Soft Tissue Infiltration with Local Anesthetic (STILA) and General Anesthesia in people with Hip Fracture Surgeries and Intertrochanteric Fracture, run by NYU Langone Health at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture Surgeries, Intertrochanteric Fracture, Femoral Hip Fracture
- What is being tested?
- Monitored Anesthesia Care (MAC), Soft Tissue Infiltration with Local Anesthetic (STILA) and General Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Oct 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
- Not yet recruiting
Northshore (Endeavor Health)
Evanston, Illinois, 60201
- Recruiting
NYU Langone Health
New York, New York, 10016
- Not yet recruiting
Jamaica Hospital
Queens, New York, 11418
- Not yet recruiting
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia for Older Adults With Hip Fracture: A Multi-Center Feasibility Randomized Clinical Trial
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.
- Being tested
- Monitored Anesthesia Care (MAC), Soft Tissue Infiltration with Local Anesthetic (STILA), General Anesthesia
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitored Anesthesia Care (MAC)Procedure or surgery
Anesthesiologist titration of intravenous sedation to a level that preserves a natural airway with spontaneous breathing.
Soft Tissue Infiltration with Local Anesthetic (STILA)Procedure or surgery
Local anesthetic injected directly into the surgical site following sedation.
General AnesthesiaProcedure or surgery
Participants will be sedated per general anesthesia procedures.
| Study group | Role | What they receive |
|---|---|---|
| MAC-STILA | Experimental | Participants will receive monitored anesthesia care with soft-tissue infiltration with local anesthesia (MAC-STILA) during surgery. Receives: Procedure: Monitored Anesthesia Care (MAC); Procedure: Soft Tissue Infiltration with Local Anesthetic (STILA) |
| General Anesthesia | Active comparator | Participants will receive general anesthesia during surgery. Receives: Procedure: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Measured: End-of-study (up to 90 days)
Percentage of completeness of data collected
Measured: End-of-study (up to 90 days)
Secondary outcomes (1)
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).
Measured: Discharge from hospital (up to 5 days postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start27 Oct 2026
- Primary completion15 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fracture SurgeriesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sanjit Konda, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897656
- Sponsor's protocol ID
- 25-01446
- Other IDs
- 5R01AG090860
- Acronym
- MAC-STILA
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia for Older Adults With Hip Fracture: A Multi-Center Feasibility Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07897656
- Acronym / sponsor ID
- MAC-STILA / 25-01446
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Oct 2026 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAC-STILA | Experimental | Procedure: Monitored Anesthesia Care (MAC), Procedure: Soft Tissue Infiltration with Local Anesthetic (STILA)Participants will receive monitored anesthesia care with soft-tissue infiltration with local anesthesia (MAC-STILA) during surgery. |
| General Anesthesia | Active comparator | Procedure: General AnesthesiaParticipants will receive general anesthesia during surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitored Anesthesia Care (MAC)Anesthesiologist titration of intravenous sedation to a level that preserves a natural airway with spontaneous breathing. | Procedure or surgery | MAC-STILA |
| Soft Tissue Infiltration with Local Anesthetic (STILA)Local anesthetic injected directly into the surgical site following sedation. | Procedure or surgery | MAC-STILA |
| General AnesthesiaParticipants will be sedated per general anesthesia procedures. | Procedure or surgery | General Anesthesia |
Primary outcome
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)
1 secondary outcome
3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) score
Time frame: Discharge from hospital (up to 5 days postoperative)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Hip Fracture Surgeries
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanjit Konda, MD principal investigator
NYU Langone Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitored Anesthesia Care (MAC), Soft Tissue Infiltration with Local Anesthetic (STILA) and General Anesthesia in people with Hip Fracture Surgeries and Intertrochanteric Fracture, run by NYU Langone Health at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shifa Ahmed (774-217-2467, shifa.ahmed@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: End-of-study (up to 90 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.