The Role of Intraoperative Navigation-assisted Channel Screw Technique in the Treatment of Pelvic Fractures

NCT05448911 | Unknown

• 1 other identifier: XJTU1AF-CRF-2020-011
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a multicenter, prospective, randomized, controlled study. Patients with pelvic fractures (Tile B and c) were recruited from the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an Red Society Hospital and Xi'an 521 hospital, the patients were randomly divided into two groups according to the Order of admission: Experimental Group (intraoperative navigation combined with channel screw technique) and Control Group (open reduction and plate internal fixation) , the difference of operative effect between the two groups was compared by fracture reduction, channel screw position, operative time, fluoroscopy frequency, hospitalization time, hospitalization cost, recovery time and Mayo Score. Use Access 2003 to build a database and store data; use SPSS 21.0. 0 Software for statistical analysis. The entire process required the development of a standardized staff manual, and all were subject to rigorous training and examination in order to participate in the pilot, and the investigation process was supervised by the project leader.

Conditions

Pelvic Fracture

Outcome Measures

Primary Outcomes (1)

• Pelvic change

  fracture displacement \< 4 mm was excellent, 4-10 mm was good, 10-20 mm was fair, and \> 20 mm was poor.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 month

Secondary Outcomes (6)

• screw position

  follow-up of 3 months, 6 months and 12 months

• pubic ramus screws

  follow-up of 3 months, 6 months and 12 months

• VAS scores VAS scores

  follow-up of 3 months, 6 months and 12 months

• The length of hospital stay

  follow-up of 3 months, 6 months and 12 months

• Total cost of hospitalization

  follow-up of 3 months, 6 months and 12 months

Study Arms (2)

Experimental group

EXPERIMENTAL

It uses minimally invasive small incisions, physiological access to the pelvis, and hollow screws for Pelvic and Acetabular fractures

Procedure: Intraoperative navigation combined with Catheter screw technique

Control Group

OTHER

This approach typically requires extensive surgical exposure and large-scale soft-tissue dissection, which quickly leads to some serious complications, including increased rates of infection, poor wound healing, increased damage to large vessels or nerves, and heterotopic ossification

Procedure: Open reduction and internal fixation with steel plate

Interventions

Intraoperative navigation combined with Catheter screw technique PROCEDURE

It uses minimally invasive small incisions, physiological access to the pelvis, and hollow screws for Pelvic and Acetabular fractures

Experimental group

Open reduction and internal fixation with steel plate PROCEDURE

Open reduction and plate internal fixation is the most commonly used method to treat pelvic fracture, which can achieve anatomical reduction and rigid fixation. However, this method requires extensive dissection of the surrounding soft-tissue fracture and is invasive

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• inpatients diagnosed with unstable pelvic acetabular fractures (tile B, C);
• sacroiliac joint dislocations and longitudinal sacral fractures that do not require sacral nerve or sacral canal decompression;

You may not qualify if:

• )stable posterior pelvic ring injury (Tile A type); 2)preoperative closed reduction to achieve functional reduction; 3)patients with severe osteoporosis; 4)heart, liver, kidney, and other essential organ lesions cannot tolerate surgery.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Hip Fractures

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: July 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: January 1, 2025
• Last Updated: August 1, 2022

Record last verified: 2022-06