Novel Quadrilateral Surface Plate for Acetabular Fracture

Fracture Dislocation Clinical Trial

Official title:

Randomized Trails of Different Fixations for Acetabular Fracture Involving Quadrilateral Surface

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03026868
• Other study ID #: HZY2016
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2017
• Last updated: December 13, 2017
• Start date: February 2015
• Est. completion date: March 2018

Study information

• Verified date: January 2017
• Source: Hebei Medical University Third Hospital
• Contact: Zhiyong Hou, M.D
• Phone: +8618533112800
• Email: houzhiyong1234[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The novel plate could be used to manage acetabular fractures involving quadrilateral surface and posterior column, which may lower the intraoperative blood loss and reduce complication rate.

Description:

Stoppa approach was more minimally invasive than ilioinguinal approach for pelvic and acetabular fractures. Then, Stoppa approach was widely used clinically. For the fragments involving quadrilateral surface, the Kocher-Langenbeck approach was added because the fixation of posterior fragments could not be obtained with reconstruction plate through single Stoppa approach. Novel quadrilateral surface plate was used in this study to examine its fixed role for posterior fragments. Functional outcome and complication were recorded to compare with the results treated with reconstruction plate. If good results were obtained for the patients fixed with quadrilateral surface plate, it was meaningful to popularize the fixed method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old

• Fracture involving quadrilateral surface

• Operation was conducted within 14 days

• Fixed with quadrilateral surface plate through Stoppa approach

Exclusion Criteria:

• Presented with a pathologic acetabular fracture

• Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable

• Refused to participate

• Follow-up insufficient 12 months

Related Conditions & MeSH terms

• Fracture Dislocation
• Fractures, Bone

Intervention

Procedure:
• quadrilateral surface plate
Both anterior and posterior approaches were always conducted to manage the fragments of quadrilateral surface. Novel quadrilateral surface plate was used in this study to examine whether the fragments could be fixed through single Stoppa approach.

Locations

Country	Name	City	State
China	Zhiyong Hou	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fracture healing time	fracture line disappeared in the radiograph	4 months
Secondary	complication	wound infection, iatrogenic injury of vessels and nerves, nonunion	1 month