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Bone Graft in Aseptic Subtrochanteric Nonunion

NCT ID: NCT04651647

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-01

Study Completion Date

2019-11-01

Brief Summary

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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

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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.

Conditions

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Subtrochanteric Nonunion

Keywords

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subtrochanteric nonunion; intramedullary nail; bone graft

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Bone graft group

The bone graft group (n=19) who underwent open nailing with open bone graft for aseptic subtrochanteric nonunion

Revision surgery with / without open bone graft

Intervention Type 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

Non bone graft group

The non-BG group (n=18) who underwent closed reamed nailing without bone graft for aseptic subtrochanteric nonunion

Revision surgery with / without open bone graft

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

32 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Yangsan Hospital

OTHER

Sponsor Role collaborator

Jae Hoon Jang

OTHER

Sponsor Role lead

Responsible Party

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Jae Hoon Jang

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Pusan National University Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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realjang

Identifier Type: -

Identifier Source: org_study_id