Clinical trial NCT05038709: Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness
Official title: Does the Addition of a Traction Pad Reduce the Rate of Postoperative Pudendal Neuralgia?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Hip Injuries
Hip Sprain
Hip Strain
Keywords: arthroscopy
traction
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Compared to the knee and shoulder, the hip joint leaves relatively little space to maneuver arthroscopic instruments and camera. To expand the potential space in the hip joint, traction is commonly applied to the operative leg through a perineal post. This is an effective technique to improve the working space for arthroscopy, however it has been associated with complications, including perineal numbness. Traction pads, used alone or with a perineal post, can reduce pressure on the perineal area, thus reducing numbness. The investigators hypothesize that positioning hip arthroscopy patients using a traction pad on a standard traction table with a perineal post will reduce the incidence and duration of postoperative perineal numbness.


Eligibility criteria: Inclusion Criteria:

* All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing hip arthroscopy
* Ability to read and speak English

Exclusion Criteria:

* Revision surgery
* Oncologic surgery
* Use of regional anesthesia
* Arthroscopic hip surgery that involves procedures other than labral repair, acetabuloplasty, CAM-plasty, IT band windowing, Iliopsoas lengthening

Primary outcomes:
measure: patient-reported post-operative numbness
timeFrame: Baseline prior to surgery
measure: patient-reported post-operative numbness
timeFrame: 72 hours after surgery
measure: patient-reported numbness
timeFrame: 1 week after surgery
measure: patient-reported numbness
timeFrame: 3 weeks after surgery
measure: patient-reported numbness
timeFrame: 6 weeks after surgery
Secondary outcomes:
measure: patient-reported difficulty urinating
timeFrame: Baseline prior to surgery
measure: patient-reported difficulty urinating
timeFrame: 72 hours after surgery
measure: patient-reported difficulty urinating
timeFrame: 1 week after surgery
measure: patient-reported difficulty urinating
timeFrame: 3 weeks after surgery
measure: patient-reported difficulty urinating
timeFrame: 6 weeks after surgery
measure: patient-reported difficulty with bowel movements
timeFrame: Baseline prior to surgery
measure: patient-reported difficulty with bowel movements
timeFrame: 72 hours after surgery
measure: patient-reported difficulty with bowel movements
timeFrame: 1 week after surgery
measure: patient-reported difficulty with bowel movements
timeFrame: 3 weeks after surgery
measure: patient-reported difficulty with bowel movements
timeFrame: 6 weeks after surgery
measure: patient-reported skin changes or breakdown
timeFrame: Baseline prior to surgery
measure: patient-reported skin changes or breakdown
timeFrame: 72 hours after surgery
measure: patient-reported skin changes or breakdown
timeFrame: 1 week after surgery
measure: patient-reported skin changes or breakdown
timeFrame: 3 weeks after surgery
measure: patient-reported skin changes or breakdown
timeFrame: 6 weeks after surgery
measure: patient-reported sexual disfunction or erectile disfunction
timeFrame: Baseline prior to surgery
measure: patient-reported sexual disfunction or erectile disfunction
timeFrame: 72 hours after surgery
measure: patient-reported sexual disfunction or erectile disfunction
timeFrame: 1 week after surgery
measure: patient-reported sexual disfunction or erectile disfunction
timeFrame: 3 weeks after surgery
measure: patient-reported sexual disfunction or erectile disfunction
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Orthopaedic Surgery
state: Illinois
Study officials:
affiliation: Northwestern University
name: Vehniah K Tjong, MD
role: PRINCIPAL_INVESTIGATOR
References: