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CompletedNCT04651647Updated Dec 3, 2020

Bone Graft in Aseptic Subtrochanteric Nonunion

An observational study in Subtrochanteric Nonunion, sponsored by Jae Hoon Jang. Completed at 1 site in Korea, Republic of. Open to participants aged 32 Years to 82 Years. Per ClinicalTrials.gov, last updated 2020-12-03.

Sponsored by Jae Hoon Jang · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
37
Ages
32 Years to 82 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Subtrochanteric Nonunion

Keywords

  • subtrochanteric nonunion; intramedullary nail; bone graft
03

In context

Lead sponsor

This is the only study on the registry with Jae Hoon Jang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
32 Years to 82 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
37 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • ProcedureRevision 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

06

What researchers measure

Primary outcomes

  1. bony union

    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.

    Time frame: The time when bone union was achieved after surgery

  2. risk factors for nonunion

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

    Time frame: One year after surgery

07

Study locations

1 site
  • Pusan National University Hospital
    Busan, 49241, Korea, Republic of
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References and documents

Individual participant data

Plan to share: Undecided — I would like to determine whether or not to share IPD after publication.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04651647
Lead sponsor
Jae Hoon Jang
Collaborators
Pusan National University Yangsan Hospital
Responsible party
Jae Hoon Jang (Associate Professor, Pusan National University Hospital) — Sponsor-investigator
First posted
Dec 3, 2020
Start date
Jan 1, 2008
Primary completion
Mar 31, 2018
Completion
Nov 1, 2019
Last update
Dec 3, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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