NCT03314623

Brief Summary

The purpose of this study is to investigate if immediate mobilization with weight bearing as tolerated following surgery with plates and screws after a fracture of the shinbone near the knee is possible without increased risk. The investigators hypothesize immediate weight bearing as tolerated following surgery with plates and screws of the above mentioned fracture, in cases deemed stable by the surgeon, will not lead to any loss of reduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

October 9, 2017

Last Update Submit

March 15, 2021

Conditions

Surgery--ComplicationsTibia FractureEarly Ambulation

Outcome Measures

Primary Outcomes (1)

  • Loss of reduction

    Loss of reduction/fracture collapse after ambulation measured by x ray

    Day 0 to one year after surgery.

Secondary Outcomes (12)

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    Day 0 to one year after surgery.

  • Return to Work

    Day 0 to one year after surgery.

  • Length of Hospital Stay

    Day 0 to one year after surgery.

  • Euroqol 5 Dimension (EQ-5D)

    Day 0 to one year after surgery.

  • The University of California at Los Angeles (UCLA) Activity Score

    Day 0 to one year after surgery.

  • +7 more secondary outcomes

Interventions

Weight bearing as toleratedBEHAVIORAL

If fracture is deemed stable the subjects will be allowed to weight bear immediately after surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Every patient hospitalized at Slagelse hospital with proximal tibial fracture needing surgery with plates and screws residing in Slagelse hospital uptake area

You may qualify if:

  • Patient hospitalized and osteosynthesized with one or several locking plates because of a proximal tibial fracture

You may not qualify if:

  • Non-ambulatory patients,
  • Patients diagnosed with dementia and
  • Patients residing to another hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Slagelse Sygehus

Slagelse, 4200, Denmark

Location

MeSH Terms

Conditions

Tibial Fractures

Interventions

Weight-Bearing

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 19, 2017

Study Start

February 1, 2018

Primary Completion

January 31, 2021

Study Completion

February 28, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

DK(1)