Evaluation of Weight Bearing After Total Hip and Knee Replacement
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ClinicalTrials.gov Identifier: NCT01135160 |
Recruitment Status
:
Recruiting
First Posted
: June 2, 2010
Last Update Posted
: August 31, 2016
|
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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.
Condition or disease |
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Arthropathy of Hip Arthropathy of Knee |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Evaluation of Weight Bearing in Patients After Total Hip and Knee Replacement |
Study Start Date : | November 2014 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2018 |
Group/Cohort |
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TKA/THA
All patients receiving TKA/THA meeting inclusion but not exclusion criteria
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- full weight bearing allowed and accomplished end of 6th week [ Time Frame: 6 weeks ]full weight bearing allowed and accomplished, documented by special soles with an electronic device, which will record weight bearing continuously on an USB stick
- pain under partial weight bearing (recommended) [ Time Frame: 6 weeks ]Patients will have a official standardised pain diary and should document their pain and need of analgetics according to instructions given (VAS, "Schweizer Krebsliga") at least on a daily basis.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- received a THA or TKA in the mentioned period of time
- is able to walk on crutches
- is able to understand our recommendations
- signed informed consent
Exclusion Criteria:
- not able to walk on crutches
- not able to understand our recommendations
- other deformities of lower limbs

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135160
Contact: Martin Blay, Dr. med. | +41-71-686-2030 | martin.blay@stgag.ch | |
Contact: Michael Schüler, Dr. med. | +41-71-686-2030 | michael.schüler@stgag.ch |
Switzerland | |
Kantonsspital Münsterlingen | Recruiting |
Münsterlingen, Thurgau, Switzerland, 8596 | |
Contact: Martin Blay, Dr. med. +41-71-686-2030 martin.blay@stgag.ch | |
Principal Investigator: Michael Schueler, Dr. med. | |
Sub-Investigator: Martin Blay, Dr. med. | |
Sub-Investigator: Lars Edelman | |
Sub-Investigator: Jaqueline Fust, Dr. med. |
Principal Investigator: | Michael Schueler, Dr. med. | Chief of the department for orthopedic surgery Kantonsspital Münsterlingen, Schweiz |
Responsible Party: | Kantonsspital Münsterlingen |
ClinicalTrials.gov Identifier: | NCT01135160 History of Changes |
Other Study ID Numbers: |
KSM 2010-1 |
First Posted: | June 2, 2010 Key Record Dates |
Last Update Posted: | August 31, 2016 |
Last Verified: | August 2016 |
Keywords provided by Kantonsspital Münsterlingen:
weight bearing pain total hip arthroplasty total knee arthroplasty weight bearing after TKA or THA |
Additional relevant MeSH terms:
Joint Diseases Musculoskeletal Diseases |