Skip to main content
OpenTrials
Completed

NCT Number: NCT04651647

Bone Graft in Aseptic Subtrochanteric Nonunion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Subtrochanteric Nonunion

Age range

32 year–82 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Hospital

Busan, 49241, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Revision surgery with / without open bone graft

Procedure

Removal of previous implant and re-alignment and re-fixation using intramedullary nail with (bone graft group) / without (non bone graft group) open bone graft

Primary outcomes

  1. bony union

    Time frame: 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.

  2. risk factors for nonunion

    Time frame: One year after surgery

    Determining when open procedure with bone graft should be considered by analyzing risk factors for nonunion.

Sponsors and collaborators

Lead sponsor

Jae Hoon Jang

Other

Collaborators

  • Pusan National University Yangsan Hospital

Registry information

Official study title

Is Open Bone Graft Always Necessary When Treating Subtrochanteric Nonunion With a Reamed Intramedullary Nail?

Important dates

Study start
2008
Primary completion
2018
Study completion
2019
First posted
Dec 3, 2020
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.