Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness

Study Overview
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Brief Summary
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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.

Official Title
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Does the Addition of a Traction Pad Reduce the Rate of Postoperative Pudendal Neuralgia?

Conditions
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Hip Osteoarthritis, Hip Injuries, Hip Sprain, Hip Strain

Intervention / Treatment
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* Device: The Pink Pad Hip Kit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pink Pad<br>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<br>* The pad is placed between the patient and the traction table to reduce pressure to the pudendal nerve exerted by the perineal post.<br>* Other names: Xodus Medical;|
| No Intervention: Control (No pad)<br>Hip arthroscopy in the usual fashion, no pad, using traction table with perineal post. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-reported difficulty urinating | Y/N Have you experienced difficulty urinating? | Baseline prior to surgery | 
| patient-reported difficulty urinating | Y/N Have you experienced difficulty urinating? | 72 hours after surgery | 
| patient-reported difficulty urinating | Y/N Have you experienced difficulty urinating? | 1 week after surgery | 
| patient-reported difficulty urinating | Y/N Have you experienced difficulty urinating? | 3 weeks after surgery | 
| patient-reported difficulty urinating | Y/N Have you experienced difficulty urinating? | 6 weeks after surgery | 
| patient-reported difficulty with bowel movements | Y/N Have you experienced difficulty with bowel movements? | Baseline prior to surgery | 
| patient-reported difficulty with bowel movements | Y/N Have you experienced difficulty with bowel movements? | 72 hours after surgery | 
| patient-reported difficulty with bowel movements | Y/N Have you experienced difficulty with bowel movements? | 1 week after surgery | 
| patient-reported difficulty with bowel movements | Y/N Have you experienced difficulty with bowel movements? | 3 weeks after surgery | 
| patient-reported difficulty with bowel movements | Y/N Have you experienced difficulty with bowel movements? | 6 weeks after surgery | 
| patient-reported skin changes or breakdown | Y/N Have you experienced skin changes or skin breakdown? | Baseline prior to surgery | 
| patient-reported skin changes or breakdown | Y/N Have you experienced skin changes or skin breakdown? | 72 hours after surgery | 
| patient-reported skin changes or breakdown | Y/N Have you experienced skin changes or skin breakdown? | 1 week after surgery | 
| patient-reported skin changes or breakdown | Y/N Have you experienced skin changes or skin breakdown? | 3 weeks after surgery | 
| patient-reported skin changes or breakdown | Y/N Have you experienced skin changes or skin breakdown? | 6 weeks after surgery | 
| patient-reported sexual disfunction or erectile disfunction | Y/N Have you experienced sexual dysfunction/erectile dysfunction? | Baseline prior to surgery | 
| patient-reported sexual disfunction or erectile disfunction | Y/N Have you experienced sexual dysfunction/erectile dysfunction? | 72 hours after surgery | 
| patient-reported sexual disfunction or erectile disfunction | Y/N Have you experienced sexual dysfunction/erectile dysfunction? | 1 week after surgery | 
| patient-reported sexual disfunction or erectile disfunction | Y/N Have you experienced sexual dysfunction/erectile dysfunction? | 3 weeks after surgery | 
| patient-reported sexual disfunction or erectile disfunction | Y/N Have you experienced sexual dysfunction/erectile dysfunction? | 6 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthroscopy, traction