Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389240
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Brief Title:
Early Weight Bearing in Unicondylar Tibial Plateau Fractures
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Early Weight Bearing in Unicondylar Tibial Plateau Fractures How Does it Affect Gait Pattern Mobility and Overall Outcome A Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures 6 weeks without weight bearing on gait patient satisfaction return to worksports and complication rate The data will be compared to a 10-12 week non-weight bearing group standard of care
It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections - but leads to improved patient satisfaction reduced return to worksports times and has a positive impact on the overall outcome
It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections - but leads to improved patient satisfaction reduced return to worksports times and has a positive impact on the overall outcome
Detailed Description:
Tibial plateau fractures are common sports injuries caused by accidents such as skiing and mountain biking Thus young adults with high functional and athletic demands are often affected The best possible restoration of the original joint function and resilience is therefore particularly important for this group of patients In addition prolonged immobilization in this patient group poses a high risk of loss of earnings and a significant impairment in athletic performance
These injuries usually require surgical treatment which is followed by 10-12 weeks without weight bearing In recent years there has been a shift towards earlier mobilization with many injuries In addition numerous studies showed the negative effects of prolonged immobility Nevertheless these negative effects must always be weighed against the possibility of osteosynthesis failure
These injuries usually require surgical treatment which is followed by 10-12 weeks without weight bearing In recent years there has been a shift towards earlier mobilization with many injuries In addition numerous studies showed the negative effects of prolonged immobility Nevertheless these negative effects must always be weighed against the possibility of osteosynthesis failure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None