Bone Graft in Aseptic Subtrochanteric Nonunion

November 25, 2020 updated by: Jae Hoon Jang

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

32 years to 82 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who visited our institutions for surgical treatment of subtrochanteric nonunion and underwent surgical intervention in the institutions.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The time when bone union was achieved after surgery
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.
One year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jae Hoon Jang

Collaborators

Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2008

Primary Completion (ACTUAL)

March 31, 2018

Study Completion (ACTUAL)

November 1, 2019

Study Registration Dates

First Submitted

November 20, 2020

First Submitted That Met QC Criteria

November 25, 2020

First Posted (ACTUAL)

December 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • realjang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I would like to determine whether or not to share IPD after publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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