Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness

NCT05038709 | Active Not Recruiting FDA Device

• 1 other identifier: STU00214620
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

arthroscopy; traction

Outcome Measures

Primary Outcomes (5)

• patient-reported post-operative numbness

  Y/N Are you experiencing complete or partial numbness prior to your surgery?

  Baseline prior to surgery

• patient-reported post-operative numbness

  Y/N Are you experiencing complete or partial numbness as a result of your surgery?

  72 hours after surgery

• patient-reported numbness

  Y/N Are you experiencing complete or partial numbness as a result of your surgery?

  1 week after surgery

• patient-reported numbness

  Y/N Are you experiencing complete or partial numbness as a result of your surgery?

  3 weeks after surgery

• patient-reported numbness

  Y/N Are you experiencing complete or partial numbness as a result of your surgery?

  6 weeks after surgery

Secondary Outcomes (20)

• patient-reported difficulty urinating

  Baseline prior to surgery

• patient-reported difficulty urinating

  72 hours after surgery

• patient-reported difficulty urinating

  1 week after surgery

• patient-reported difficulty urinating

  3 weeks after surgery

• patient-reported difficulty urinating

  6 weeks after surgery

Study Arms (2)

Pink Pad

EXPERIMENTAL

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.

Device: The Pink Pad Hip Kit

Control (No pad)

NO INTERVENTION

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

Interventions

The Pink Pad Hip Kit DEVICE

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

Also known as: Xodus Medical

Pink Pad

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Orthopaedic Surgery

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Hip Injuries

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Wounds and Injuries

Study Officials

• Vehniah K Tjong, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 9, 2021
• Study Start: October 12, 2021
• Primary Completion: December 11, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)