NCT04940754

Brief Summary

Tibial pseudarthrosis in 83 year old patient suffering from pathologic fractures

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

April 8, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2022

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

June 10, 2021

Last Update Submit

August 14, 2021

Conditions

Bone MetastasesFracture NonunionBone Lesion

Keywords

fragility fracture, old age

Outcome Measures

Primary Outcomes (1)

  • Weight bearing tolerance

    Measuring walking distance

    1 year

Study Arms (1)

Stabilzation of Fracture

OTHER

Arthrodesis nail used for stabilzation of a fracture, single patient

Procedure: osteosynthesis

Interventions

osteosynthesisPROCEDURE

Closed reduction, internal fixation

Stabilzation of Fracture

Eligibility Criteria

Age80 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \- old age, fragility fracture, tibia

You may not qualify if:

  • active osteomyelitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedie Zentrum Zuerich

Zurich, 8027, Switzerland

Location

MeSH Terms

Conditions

Fractures, Ununited

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Use of an approved implant for expanded application
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 28, 2021

Study Start

April 8, 2021

Primary Completion

April 8, 2022

Study Completion

May 8, 2022

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations

CH(1)