Hip OsteoarthritisNCT05038709
Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness
A study testing The Pink Pad Hip Kit in people with Hip Osteoarthritis and Hip Injuries, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Hip Osteoarthritis, Hip Injuries, Hip Sprain
- What is being tested?
- The Pink Pad Hip Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Orthopaedic Surgery
Chicago, Illinois, 60611
About this study
Official title: Does the Addition of a Traction Pad Reduce the Rate of Postoperative Pudendal Neuralgia?
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
- Being tested
- The Pink Pad Hip Kit
- Keywords
- arthroscopy, traction
- Medical subject headings
- Osteoarthritis, Hip, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Pink Pad Hip KitDevice
Also called Xodus Medical
The pad is placed between the patient and the traction table to reduce pressure to the pudendal nerve exerted by the perineal post.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-reported post-operative numbness
Y/N Are you experiencing complete or partial numbness prior to your surgery?
Measured: Baseline prior to surgery
patient-reported post-operative numbness
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
Measured: 72 hours after surgery
patient-reported numbness
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
Measured: 1 week after surgery
patient-reported numbness
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
Measured: 3 weeks after surgery
patient-reported numbness
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
Measured: 6 weeks after surgery
Secondary outcomes (20)
patient-reported difficulty urinating
Y/N Have you experienced difficulty urinating?
Measured: Baseline prior to surgery
patient-reported difficulty urinating
Y/N Have you experienced difficulty urinating?
Measured: 72 hours after surgery
patient-reported difficulty urinating
Y/N Have you experienced difficulty urinating?
Measured: 1 week after surgery
patient-reported difficulty urinating
Y/N Have you experienced difficulty urinating?
Measured: 3 weeks after surgery
patient-reported difficulty urinating
Y/N Have you experienced difficulty urinating?
Measured: 6 weeks after surgery
patient-reported difficulty with bowel movements
Y/N Have you experienced difficulty with bowel movements?
Measured: Baseline prior to surgery
patient-reported difficulty with bowel movements
Y/N Have you experienced difficulty with bowel movements?
Measured: 72 hours after surgery
patient-reported difficulty with bowel movements
Y/N Have you experienced difficulty with bowel movements?
Measured: 1 week after surgery
patient-reported difficulty with bowel movements
Y/N Have you experienced difficulty with bowel movements?
Measured: 3 weeks after surgery
patient-reported difficulty with bowel movements
Y/N Have you experienced difficulty with bowel movements?
Measured: 6 weeks after surgery
patient-reported skin changes or breakdown
Y/N Have you experienced skin changes or skin breakdown?
Measured: Baseline prior to surgery
patient-reported skin changes or breakdown
Y/N Have you experienced skin changes or skin breakdown?
Measured: 72 hours after surgery
patient-reported skin changes or breakdown
Y/N Have you experienced skin changes or skin breakdown?
Measured: 1 week after surgery
patient-reported skin changes or breakdown
Y/N Have you experienced skin changes or skin breakdown?
Measured: 3 weeks after surgery
patient-reported skin changes or breakdown
Y/N Have you experienced skin changes or skin breakdown?
Measured: 6 weeks after surgery
patient-reported sexual disfunction or erectile disfunction
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
Measured: Baseline prior to surgery
patient-reported sexual disfunction or erectile disfunction
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
Measured: 72 hours after surgery
patient-reported sexual disfunction or erectile disfunction
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
Measured: 1 week after surgery
patient-reported sexual disfunction or erectile disfunction
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
Measured: 3 weeks after surgery
patient-reported sexual disfunction or erectile disfunction
Y/N Have you experienced sexual dysfunction/erectile dysfunction?
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start12 Oct 2021
- Primary completion11 Dec 2025
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vehniah Tjong, Northwestern University
- Investigators
- Vehniah K Tjong, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038709
- Sponsor's protocol ID
- STU00214620
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes