Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 88 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05038709
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Northwestern University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Vehniah K Tjong, MD
Principal Investigator Affiliation Northwestern University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hip Osteoarthritis, Hip Injuries, Hip Sprain, Hip Strain
Arms & Interventions

Arms

Experimental: Pink Pad

Hip arthroscopy using The Pink Pad Hip Kit Patient Positioning System (Xodus Medical, New Kensington, PA). The pad is placed between the patient and the traction table, using a perineal post.

No Intervention: Control (No pad)

Hip arthroscopy in the usual fashion, no pad, using traction table with perineal post.

Interventions

Device: - The Pink Pad Hip Kit

The pad is placed between the patient and the traction table to reduce pressure to the pudendal nerve exerted by the perineal post.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chicago, Illinois

Status

Recruiting

Address

Northwestern University Department of Orthopaedic Surgery

Chicago, Illinois, 60611

Site Contact

Joshua Barrett, BS

[email protected]

312-472-6715