Positioning Technique for Hip Surgery

Overseen By Melissa J Shauver, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Revision, Oncologic, Regional anesthesia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Surgery day

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for positioning patients during hip arthroscopy, a type of surgery on the hip joint. The goal is to determine if a special traction pad, called The Pink Pad Hip Kit, used with standard equipment, can reduce numbness around the groin area post-surgery. Participants will undergo surgery either with this new pad or the usual method without it. Eligible candidates are those scheduled for specific types of hip arthroscopy at Northwestern Memorial Hospital who can read and speak English. As an unphased trial, this study allows participants to contribute to innovative surgical techniques that may enhance recovery experiences for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this positioning technique is safe for hip surgery?

Research shows that using The Pink Pad Hip Kit during hip surgery can enhance safety. This device stabilizes patients and provides the necessary traction without a perineal post, which can sometimes cause temporary groin numbness. Studies indicate that positioning pads like The Pink Pad reduce pressure and increase patient comfort.

Reports suggest that complications, such as nerve problems, occur in up to 4.3% of cases with traditional methods. However, The Pink Pad lowers these risks by ensuring safer patient positioning. Overall, the device improves procedure safety by reducing the likelihood of these issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new positioning technique for hip arthroscopic surgery using The Pink Pad Hip Kit Patient Positioning System. Unlike standard procedures that don't use additional padding, this system introduces a specialized pad to enhance patient stability on the traction table. This could potentially increase comfort and reduce complications associated with the traditional method, which relies solely on a perineal post. By improving positioning, the Pink Pad may lead to better surgical outcomes and a more comfortable experience for patients undergoing hip surgery.

What evidence suggests that this positioning technique is effective for hip arthroscopic surgery?

Research has shown that the Pink Pad, a device used during hip surgery, can significantly reduce pressure on the area between the legs. In this trial, one group of participants will undergo hip arthroscopy using the Pink Pad. Studies have demonstrated that it lowers peak pressure by 43%, potentially reducing the risk of issues like numbness in that area. The pad creates grip between the patient, the pad, and the bed, allowing doctors to access the hip joint without excessive force. This method aims to make the surgery more comfortable and reduce postoperative issues. These findings suggest that using the Pink Pad during surgery could lead to better outcomes. ^{1 2 4 6 7}

Who Is on the Research Team?

Vehniah K Tjong, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for English-speaking patients at Northwestern Memorial Hospital or its orthopaedic clinics who are undergoing hip arthroscopy for conditions like osteoarthritis or hip strain. It's not open to those who've had previous surgeries, cancer-related surgery, or will receive regional anesthesia.

Inclusion Criteria

I am getting hip arthroscopy at Northwestern Memorial Hospital or by a Northwestern orthopaedic surgeon.

Exclusion Criteria

I am scheduled for or have had revision surgery.

I have undergone surgery for cancer.

I will be using regional anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hip arthroscopy using either The Pink Pad Hip Kit Patient Positioning System or the usual method without a pad

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for postoperative numbness and other complications

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Positioning for Hip Arthroscopic Surgery
• The Pink Pad Hip Kit

Trial Overview The study tests the Pink Pad Hip Kit during hip arthroscopic surgery to see if it reduces postoperative numbness. The kit is used with a standard traction table and perineal post to lessen pressure on the groin area during surgery.

How Is the Trial Designed?

Group I: Pink Pad Experimental Treatment 1 Intervention

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 II: Control (No pad) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

The supine position for hip arthroscopy was successfully used in 20 consecutive patients, demonstrating its effectiveness and reproducibility in the surgical procedure.

This technique is user-friendly for both surgeons and operating room staff, utilizing standard equipment with only minor modifications, which enhances its practicality in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip arthroscopy utilizing the supine position. Byrd, JW.[2019]

Hip arthroscopy in the supine position is an effective and reproducible procedure, offering advantages like easier patient positioning and optimal access for portal placements.

The success and safety of the procedure rely on meticulous attention to technical details, including equipment, patient positioning, and understanding of arthroscopic anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip arthroscopy: the supine position. Byrd, JW.[2005]

Hip arthroscopy is an effective method for diagnosing and treating various hip conditions, utilizing a minimally invasive approach that enhances patient recovery.

Standardizing patient positioning and surgical setup during hip arthroscopy improves both patient safety and the efficiency of the surgical team, leading to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic Hip Arthroscopy: Supine Patient Positioning and Dynamic Fluoroscopic Evaluation. Mannava, S., Howse, EA., Stone, AV., et al.[2022]

Hip arthroscopy is a valuable tool for diagnosing and treating various hip joint conditions, but it requires specific training and knowledge of hip anatomy to minimize complications, particularly those related to joint traction.

The technique allows for a comprehensive inspection and treatment of the hip joint through multiple portals, with promising early results indicating its effectiveness for conditions like labral lesions and loose bodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hip arthroscopy. Minimal invasive diagnosis and therapy of the diseased or injured hip joint]. Dienst, M., Kohn, D.[2019]

In a study of 908 patients undergoing primary hip arthroscopy, the overall complication rate was found to be low at 7.3%, with minor complications occurring in 4.9% of cases and major complications in 2.4%.

The most common severe complications included iatrogenic cartilage damage and instrument breakage, while perineal hypoaesthesia and heterotopic ossifications were the most frequent minor complications, highlighting the importance of surgeon training and experience in minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of primary hip arthroscopy complications in mid-term follow-up: a multicentric prospective study. Zeman, P., Rafi, M., Kautzner, J.[2022]

In a study of 18 patients (9 with prior lower-extremity arthroplasty and 9 without), hip arthroscopy using traction resulted in significant improvements in hip function scores for both groups, indicating its efficacy.

The procedure was found to be safe, with only one postoperative complication in the group with prior arthroplasty, suggesting that traction during hip arthroscopy does not increase the risk of complications in patients with previous joint surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip arthroscopy outcomes, complications, and traction safety in patients with prior lower-extremity arthroplasty. Beutel, BG., Collins, JA., Garofolo, G., et al.[2022]

A systematic review of 130 studies involving 16,970 patients showed significant variability in patient-reported outcome (PRO) measures used after hip arthroscopy, with over 20 different instruments identified, complicating comparisons across studies.

The International Hip Outcome Tool (iHOT)-12 and the Nonarthritic Hip Score (NAHS) were found to be the most responsive PRO tools, suggesting that adopting standardized measures like the iHOT could improve the clarity and effectiveness of outcome reporting in hip arthroscopy research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Degree of Variability in Reporting of Clinical and Patient-Reported Outcomes After Hip Arthroscopy. Stone, AV., Jacobs, CA., Luo, TD., et al.[2022]

Arthroscopic hip surgery has become a widely accepted procedure due to advancements in surgical tools and techniques, allowing for less invasive treatment of conditions that previously required large incisions.

This procedure is performed on the same day and relies on effective teamwork among surgeons and nursing staff to ensure successful outcomes and reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic hip surgery. Shugars, RA., More, RC.[2019]

Hip arthroscopy is an effective minimally invasive procedure for treating various hip disorders, including labral lesions and moderate osteoarthritis, with good outcomes reported when performed correctly.

The technique requires careful positioning and distraction of the joint, but when done properly, complications are rare, highlighting its safety and efficacy in managing hip conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Arthroscopy of the hip]. Rühmann, O., Börner, C., Bohnsack, M., et al.[2017]

Arthroscopy of the hip has shown promising results in younger patients with localized cartilage defects, leading to symptom improvement, while older patients with widespread osteoarthritis often require total hip replacement within one to two years after the procedure.

The technique involves mechanical distraction and specialized instruments, allowing for effective visualization and treatment of the hip joint, with a low incidence of postoperative neurological symptoms, although potential complications such as cartilage damage and infection must be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopy of the hip. Hawkins, RB.[2005]

A multicenter study involving 303 patients showed significant improvements in pain and hip function scores after arthroscopic labral repair, with follow-up averaging 5.7 years.

However, factors such as a BMI over 30, age over 35, and preoperative Tönnis grade 2 changes were associated with poorer outcomes, indicating that these may be important considerations for patient selection and prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Analysis of Midterm Clinical Outcomes of Arthroscopic Labral Repair in the Hip: Minimum 5-Year Follow-up. Hevesi, M., Krych, AJ., Johnson, NR., et al.[2019]

Hip arthroscopy is generally a safe procedure with favorable early results, but it can still lead to complications, some of which may be serious and underreported, such as acetabular labral puncture.

To minimize complications, it is crucial for surgeons to have proper education, training, and to follow meticulous surgical techniques, as well as to choose the right patients for the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in Hip Arthroscopy. Nakano, N., Khanduja, V.[2020]

The article provides a comprehensive overview of essential concepts for hip arthroscopy, including optimal room setup, necessary equipment, and patient positioning, which are crucial for successful procedures.

It evaluates the benefits of different patient positions (lateral vs. supine) and discusses common arthroscopic portal placements, highlighting the importance of technique in minimizing potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanics of hip arthroscopy. Boyle, JR., Silva, JA., Mc Millan, S., et al.[2011]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8355178/

A Method of Post-Free Distraction During Hip Arthroscopy - PMC The pink pad positioning device allows for post-free distraction through the creation of friction between the patient, the pad, and the bed.

2. xodusmedical.com xodusmedical.com/PinkHipKit

The Pink Hip Kit - Postless Hip Positioning System by ... In a study of 15 subjects ranging from 16-54 BMI (average BMI 35.5), the Pink Pad provided an average peak pressure reduction of 43%. US Government Data show ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S221262872400063X

Postless Distraction Technique With No Additional ... Achieving post-free distraction in hip arthroscopy with a pink pad patient positioning device using standard hip distraction tables. Arthrosc Tech, 8 (2019) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11705001/

Hip Arthroscopy with and Without A Perineal Post The purpose of this study is to compare postoperative pain and early recovery after hip arthroscopy with and without a perineal post for joint ...

5. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(24)00360-8/fulltext

Basic Hip Arthroscopy Part 1: Patient Positioning and ... In this 3-part series, the authors will aim to comprehensively review the fundamentals of hip arthroscopy in the setting of femoroacetabular impingement.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2212628718302020

Achieving Post-Free Distraction in Hip Arthroscopy With a ... Iatrogenic pudendal nerve and groin complications have been reported to occur at rates up to 4.3%. While many of these complications are transient, the hip ...

7. withpower.com withpower.com/trial/phase-hip-injuries-9-2021-c99fd

Positioning Technique for Hip Surgery This suggests that proper positioning, like using The Pink Pad Hip Kit, can enhance the effectiveness and safety of hip arthroscopic procedures.