Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT01135160
Status:
TERMINATED
Last Update Posted:
2024-10-18
First Post:
2010-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Weight Bearing After Total Hip and Knee Replacement
Sponsor:
Kantonsspital Münsterlingen
Organization:
Study Overview
Official Title:
Evaluation of Weight Bearing in Patients After Total Hip and Knee Replacement
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The planned number of patients was achieved.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The regime in the aftercare after total hip and knee arthroplasty(THA/TKA) differs a lot between orthopedic surgeons concerning weight bearing. The type of implant and the way of implants' anchoring are considered.
In the literature there is no data so far about the way patient take care of the recommended weight bearing during the first 6 weeks after THA and TKA.
Over a one year period starting August 2010 all patients undergoing TKA or THA at the investigators institution will have a technical device in their shoes (sole) to measure the load in each step they do in these shoes during the first 6 weeks. Patients are asked to fill out a standardised pain protocol every day (VAS) and document need of pain medication. The investigators recommend 20kg of weight on the operated leg for 6 weeks and full weight bearing at the end of week six.
The investigators believe that patients will adjust weight bearing to their level of pain and not to their surgeons recommendations.
In the literature there is no data so far about the way patient take care of the recommended weight bearing during the first 6 weeks after THA and TKA.
Over a one year period starting August 2010 all patients undergoing TKA or THA at the investigators institution will have a technical device in their shoes (sole) to measure the load in each step they do in these shoes during the first 6 weeks. Patients are asked to fill out a standardised pain protocol every day (VAS) and document need of pain medication. The investigators recommend 20kg of weight on the operated leg for 6 weeks and full weight bearing at the end of week six.
The investigators believe that patients will adjust weight bearing to their level of pain and not to their surgeons recommendations.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: