Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07348614
Phase
PHASE4
Status
Recruiting

Conditions

  • Knee Stiffness After Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Spinal Anesthesia — PROCEDURE
    Administration of spinal anesthesia for knee manipulation.
  • General Anesthesia — PROCEDURE
    Administration of general anesthesia for knee manipulation.
  • Propofol — DRUG
    Patients undergoing general anesthesia will receive an induction dose of propofol that will be titrated to effect, and airway support as needed until the patient is appropriately anesthetized for the procedure as determined by the anesthesia and surgical care teams.
  • Chloroprocaine — DRUG
    Patients undergoing spinal anesthesia will receive a spinal injection under standard aseptic technique, with 45mg chloroprocaine.

Study Details

The purpose of this study is to determine if changing the type of anesthesia improves the outcomes of manipulation and pain control after the procedure. The study will compare a spinal anesthesia with a general anesthesia, to see if there is a better outcome from either anesthesia type.

Key Dates

Start date
Jun 1, 2026
Status verified
Jan 2026
Primary completion
Aug 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Spinal Anesthesia
    Patients receive spinal anesthesia during MUA (manipulation under anesthesia).
  • Active Comparator: General Anesthesia
    Patients receive general anesthesia during MUA (manipulation under anesthesia).

Primary Outcome Measure

Change in degrees of motion of the affected knee [ Time Frame: At time of procedure completion ]

Locations (1)

FacilityCityStateZIP
Duke University Health SystemDurhamNorth Carolina27705

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