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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Positioning for Hip Arthroscopic Surgery, The Pink Pad Hip Kit, The Pink Pad Hip Kit, Traction pad?

Research indicates that hip arthroscopy performed with the patient in the supine position is effective and reproducible, with benefits such as ease of positioning and optimal access for surgery. This suggests that proper positioning, like using The Pink Pad Hip Kit, can enhance the effectiveness and safety of hip arthroscopic procedures. ^{1 2 3 4 5}

Is the Positioning Technique for Hip Surgery generally safe for humans?

Hip arthroscopy, which includes positioning techniques, is generally considered safe with a low complication rate, although some complications can occur and may lead to significant issues. ^{2 6 7 8 9}

How does the positioning technique for hip arthroscopic surgery differ from other treatments for hip conditions?

The positioning technique for hip arthroscopic surgery, specifically using the supine position, is unique because it simplifies patient positioning and uses standard operating room equipment with minor modifications. This approach provides optimal access for portal placements and is user-friendly for both the surgeon and operating room staff, making it an effective and reproducible procedure. ^{2 10 11 12 13}

Research Team

Vehniah K Tjong, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Ability to read and speak English

Exclusion Criteria

I am scheduled for or have had revision surgery.

I have undergone surgery for cancer.

I will be using regional anesthesia.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

High Degree of Variability in Reporting of Clinical and Patient-Reported Outcomes After Hip Arthroscopy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Hip arthroscopy: the supine position. [2005]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Basic Hip Arthroscopy: Supine Patient Positioning and Dynamic Fluoroscopic Evaluation. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Arthroscopic hip surgery. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Mechanics of hip arthroscopy. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Multicenter Analysis of Midterm Clinical Outcomes of Arthroscopic Labral Repair in the Hip: Minimum 5-Year Follow-up. [2019]

7. Italy pubmed.ncbi.nlm.nih.gov

Complications in Hip Arthroscopy. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of primary hip arthroscopy complications in mid-term follow-up: a multicentric prospective study. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Hip arthroscopy outcomes, complications, and traction safety in patients with prior lower-extremity arthroplasty. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Hip arthroscopy utilizing the supine position. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

[Hip arthroscopy. Minimal invasive diagnosis and therapy of the diseased or injured hip joint]. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Arthroscopy of the hip]. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Arthroscopy of the hip. [2005]