Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID06365112

The Endoscopic Surgical Technique of the Acetabulum: A Minimally Invasive Operative Technique for the Extraperitoneal Fixation of Acetabulum Fractures

Led by Tampere University Hospital · Updated on 2024-04-24

13

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new endoscopic surgical technique to treat acetabulum fractures, which are breaks in the socket of the hip bone. These fractures can result from falls in older adults or high-energy accidents in younger people. Traditional surgery involves open procedures, but this study aims to develop a less invasive method using endoscopy to improve safety and patient outcomes. The study involves three parts: first developing the endoscopic surgical method using cadavers, then testing it prospectively in patients, and finally conducting a randomized controlled trial comparing the new endoscopic technique with the current standard open surgery called the modified Stoppa approach. The endoscopic method involves operating through small incisions using an extraperitoneal approach similar to hernia repair surgeries. Participants will be monitored for operation time, major and minor complications within three months, and patient satisfaction over about one year using health questionnaires. The study will include adults with anterior acetabular fractures suitable for the endoscopic method. Those with previous lower abdominal surgery or under 18 years old will be excluded. The trial will help determine if the new technique reduces surgery time, blood loss, and improves recovery compared to traditional surgery.

CONDITIONS

Brief Title

Endoscopic Acetabulum Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acetabulum fracture
  • Age 18 years or older
  • Anterior acetabulum fracture suitable for endoscopic treatment
Not Eligible

You will not qualify if you...

  • Under 18 years old
  • Previous lower abdominal operation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of surgical procedure and immediate recovery

Participants receive either the novel endoscopically assisted surgical treatment or the standard open reduction surgery for anterior acetabular fractures.

1 hospital stay for surgery and immediate post-operative care

Follow-up

Duration - Up to 1 year

Participants are monitored post-operatively to assess complications, patient satisfaction, and recovery outcomes.

Approximately 3 follow-up visits over 1 year

Trial Site Locations

Total: 1 location

1

Tampere University hospital

Tampere, Finland, 33521

Actively Recruiting

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Research Team

P

Piia Suomalainen

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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