Bone Graft in Aseptic Subtrochanteric Nonunion

Completed

• Conditions: Subtrochanteric Nonunion
• Interventions: Procedure: Revision surgery with / without open bone graft

• Registration Number: NCT04651647
• Lead Sponsor: Jae Hoon Jang

Brief Summary

This study aimed to compare the radiologic results between closed nailing without bone graft (BG) and open nailing with BG for subtrochanteric nonunion and to determine when open BG should be considered.

Detailed Description

In this retrospective study, we investigated the patients who underwent surgical intervention for subtrochanteric nonunion between January 2008 and March 2018 in two institutions. The cases with infection, large bone defect, pathologic fracture, open fracture, previous surgery using plate, and follow-up less than 1 year were excluded. We compared the demographic details and radiologic results between patients who underwent the open procedure with BG (BG group) and the closed procedure without BG (non-BG group) as a historical control, and risk factors for the failure of revision surgery were evaluated.

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2018-03-31
• Study Completion: 2019-11-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Patients who underwent surgical intervention using intramedullary nailing for aseptic subtrochanteric nonunion

Exclusion Criteria

• The cases with infection, large bone defect, pathologic fracture, open fracture, previous and revision surgery using plate, and follow-up less than 1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bone graft group	Revision surgery with / without open bone graft	The bone graft group (n=19) who underwent open nailing with open bone graft for aseptic subtrochanteric nonunion
Non bone graft group	Revision surgery with / without open bone graft	The non-BG group (n=18) who underwent closed reamed nailing without bone graft for aseptic subtrochanteric nonunion

Primary Outcome Measures

Name	Time	Method
risk factors for nonunion	One year after surgery	Determining when open procedure with bone graft should be considered by analyzing risk factors for nonunion.
bony union	The time when bone union was achieved after surgery	Union was defined as painless full weight bearing with the absence of fracture line or bridging callus across at least three cortices on the AP and lateral views.

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of