Subtrochanteric NonunionNCT04651647
Bone Graft in Aseptic Subtrochanteric Nonunion
An observational study of Subtrochanteric Nonunion, run by Jae Hoon Jang at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 32 to 82 years
- Conditions the study is for
- Subtrochanteric Nonunion
- What is being tested?
- Revision surgery with / without open bone graft
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2008to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visited our institutions for surgical treatment of subtrochanteric nonunion and underwent surgical intervention in the institutions.
Who may be able to join
- Patients who underwent surgical intervention using intramedullary nailing for aseptic subtrochanteric nonunion
Who cannot join
- The cases with infection, large bone defect, pathologic fracture, open fracture, previous and revision surgery using plate, and follow-up less than 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Subtrochanteric Nonunion
- Being tested
- Revision surgery with / without open bone graft
- Keywords
- subtrochanteric nonunion; intramedullary nail; bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revision surgery with / without open bone graftProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Bone graft group | The bone graft group (n=19) who underwent open nailing with open bone graft for aseptic subtrochanteric nonunion Receives: 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 Receives: Procedure: Revision surgery with / without open bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The time when bone union was achieved after surgery
risk factors for nonunion
Determining when open procedure with bone graft should be considered by analyzing risk factors for nonunion.
Measured: One year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Jan 2008
- Primary completion31 Mar 2018
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subtrochanteric NonunionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jae Hoon Jang
- Sponsor type
- University, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital
- Responsible party
- Sponsor-investigator, Jae Hoon Jang, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651647
- Sponsor's protocol ID
- realjang
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I would like to determine whether or not to share IPD after publication.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Open Bone Graft Always Necessary When Treating Subtrochanteric Nonunion With a Reamed Intramedullary Nail?
- ClinicalTrials.gov ID
- NCT04651647
- Acronym / sponsor ID
- realjang
- Conditions
- Subtrochanteric Nonunion
- Keywords
- subtrochanteric nonunion; intramedullary nail; bone graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Jae Hoon JangUniversity, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone graft group | – | Procedure: Revision surgery with / without open bone graftThe bone graft group (n=19) who underwent open nailing with open bone graft for aseptic subtrochanteric nonunion |
| Non bone graft group | – | Procedure: Revision surgery with / without open bone graftThe non-BG group (n=18) who underwent closed reamed nailing without bone graft for aseptic subtrochanteric nonunion |
Who may qualify
- Ages
- 32 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited our institutions for surgical treatment of subtrochanteric nonunion and underwent surgical intervention in the institutions.
Key inclusion criteria (1 listed)
- Patients who underwent surgical intervention using intramedullary nailing for aseptic subtrochanteric nonunion
Key exclusion criteria (1 listed)
- The cases with infection, large bone defect, pathologic fracture, open fracture, previous and revision surgery using plate, and follow-up less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revision surgery with / without open bone graftRemoval of previous implant and re-alignment and re-fixation using intramedullary nail with (bone graft group) / without (non bone graft group) open bone graft | Procedure or surgery | Bone graft group, Non bone graft group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: Undecided. I would like to determine whether or not to share IPD after publication.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subtrochanteric Nonunion, run by Jae Hoon Jang at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bony union (time frame: The time when bone union was achieved after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.