Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness

NCT ID: NCT05038709

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2026-12-31

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.

Conditions

Hip Osteoarthritis; Hip Injuries; Hip Sprain; Hip Strain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

The Pink Pad Hip Kit

Intervention Type: DEVICE

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

Control (No pad)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Xodus Medical

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Vehniah Tjong

Assistant Professor of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vehniah K Tjong, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Department of Orthopaedic Surgery

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melissa J Shauver, MPH

Role: CONTACT

melissa.shauver1@nm.org

312-472-6024

Joshua Barrett, BS

Role: CONTACT

joshua.barrett@nm.org

312-472-6715

Facility Contacts

Joshua Barrett, BS

Role: primary

joshua.barrett@northwestern.edu

3124726715

Other Identifiers

STU00214620

Identifier Type: -

Identifier Source: org_study_id