Total Extraperitoneal Approach in Orthopedic Surgery

October 8, 2024 updated by: Vedat Öztürk, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Total Extraperitoneal Approach in Orthopedic Surgery (O-TEP); Preliminary Clinical Outcomes of Symphysial Plating in Fifteen Cases: A Case Series'

The goal of this retrospective observational study is to evaluate the preliminary clinical and functional outcomes of total extraperitoneal approach (O-TEP) symphysial plating in patients with pubic symphysis diastasis (PSD). The study involved 15 patients (90% male, mean age 40) treated between March 2022 and May 2024.

The main questions it aims to answer are:

What are the clinical outcomes (e.g., VAS scores, Iowa Pelvic Scores, Majeed scores) following O-TEP symphysial plating? What are the surgical outcomes, including operating time, blood loss, and complications, associated with this minimally invasive technique?

Participants underwent:

Total extraperitoneal endoscopic symphysial plating, with follow-up assessments including postoperative pain scores, radiographs, and functional outcome evaluations using the Iowa Pelvic and Majeed scores.

Researchers will analyze the outcomes to see if this approach offers advantages over traditional open surgery, potentially reducing complications and improving recovery in PSD patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34147
        • Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Orthopedics and Traumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study population consists of patients aged 18-65 years who were diagnosed with pubic symphysis diastasis (PSD) and underwent total extraperitoneal endoscopic symphysial plating (O-TEP) at a Level 1 trauma center between March 2022 and May 2024. Patients included had a minimum follow-up period of 12 months and provided informed consent for the procedure and study participation.

Description

Inclusion Criteria:

  • Patients diagnosed with pubic symphysis diastasis (PSD).
  • Patients who underwent total extraperitoneal endoscopic symphysial plating (O-TEP) between March 2022 and May 2024.
  • Patients with a follow-up period of at least 12 months.
  • Patients who provided informed consent for the surgical procedure and the study.

Exclusion Criteria:

  • Patients who required conversion to open surgery during the procedure (e.g., due to pneumoperitoneum).
  • Patients with a follow-up period of less than 12 months.
  • Patients with incomplete clinical or radiological data.
  • Patients with contraindications to endoscopic surgery.
  • Patients who did not provide informed consent for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
O-TEP Symphysial Plating Cohort
This cohort consists of 15 patients with pubic symphysis diastasis (PSD) who underwent total extraperitoneal endoscopic symphysial plating (O-TEP) between March 2022 and May 2024. The interventions include a minimally invasive plating procedure aimed at evaluating clinical outcomes, such as postoperative pain, functional recovery, and complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating Time
Time Frame: 24 hours (after surgical procedure)
Time taken to complete the surgical procedure.
24 hours (after surgical procedure)
Intraoperative Blood Loss
Time Frame: 24 hours (after surgical procedure)
Amount of blood lost during the surgical procedure.
24 hours (after surgical procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain (VAS Scores)
Time Frame: until the final follow-up (12 to 25 months)
The VAS is scored from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.
until the final follow-up (12 to 25 months)
Hospital Stay Duration
Time Frame: From the day of surgery until discharge (typically 2 to 4 days). Unit of Measure: Days
The total number of days the patient stays in the hospital from the day of surgery until discharge.
From the day of surgery until discharge (typically 2 to 4 days). Unit of Measure: Days
Complications
Time Frame: From the day of surgery until the final follow-up (12 to 25 months). Unit of Measure: Number of patients with complications.
Any postoperative complications, including infection, implant failure, or the need for revision surgery.
From the day of surgery until the final follow-up (12 to 25 months). Unit of Measure: Number of patients with complications.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

October 6, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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