NCT05423561

Brief Summary

In 12 patients with corticalization and hypertrophic pseudarthrosis were present after dynamization, the old nail was removed and nail exchange was performed with a longer and larger diameter nail to pass the region formed in the cortex approximately 2-3cm inferior from the old nail.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

10.6 years

First QC Date

June 9, 2022

Last Update Submit

June 14, 2022

Conditions

Pseudoarthrosis of BoneImplant Breakage

Keywords

hypertrophic pseudarthrosisdynamizationcorticalisation

Outcome Measures

Primary Outcomes (2)

  • Provide Bone Union

    Achievement of bone union with detecting callus formation on radiography after passing the region of corticalisation with a longer and thicker nail

    6 months

  • Relieving pain in the nonunion area

    Detection of reduction of pain scores in the nonunion area and enabling patients to load on the extremity in the early period postoperatively

    6 weeks

Study Arms (1)

hypertrophic non-union developing after femoral transverse diaphyseal fractures

OTHER
Procedure: exchange nailing with larger, thicker nail crossing corticalization

Interventions

exchange nailing with larger, thicker nail crossing corticalizationPROCEDURE

exchange nailing with larger, thicker nail crossing corticalization

hypertrophic non-union developing after femoral transverse diaphyseal fractures

Eligibility Criteria

Age28 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subtrochanteric fractures
  • Nonunion with Pain

You may not qualify if:

  • Infection
  • Pathological Fracture (Tumor)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 21, 2022

Study Start

January 1, 2010

Primary Completion

July 31, 2020

Study Completion

May 5, 2022

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share