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Evaluation of Weight Bearing After Total Hip and Knee Replacement

This study is not yet open for participant recruitment.
Verified February 2012 by Kantonsspital Münsterlingen
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Münsterlingen
ClinicalTrials.gov Identifier:
NCT01135160
First received: March 16, 2010
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Arthroplasty, Replacement, Hip
Total Knee Arthroplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Weight Bearing in Patients After Total Hip and Knee Replacement

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kantonsspital Münsterlingen:

Primary Outcome Measures:
  • full weight bearing allowed and accomplished end of 6th week [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    full weight bearing allowed and accomplished, documented by special soles with an electronic device, which will record weight bearing continuously on an USB stick


Secondary Outcome Measures:
  • pain under partial weight bearing (recommended) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
TKA/THA
All patients receiving TKA/THA meeting inclusion but not exclusion criteria

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

all patients receiving TKA or THA at our institution between August 2010 and August 2011

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135160

Contacts
Contact: Michael Schueler, Dr. med. +41-71-686-2030 michael.schueler@stgag.ch
Contact: Emanuel Odstrcilik, Dr. med. +41-71-686-2030 emanuel.odstrcilik@stgag.ch

Locations
Switzerland
Kantonsspital Münsterlingen Not yet recruiting
Münsterlingen, Thurgau, Switzerland, 8596
Contact: Michael Schueler, Dr. med.     +41-71-686-2030     michael.schueler@stgag.ch    
Principal Investigator: Michael Schueler, Dr. med.            
Sub-Investigator: Emanuel Odstrcilik, Dr. med.            
Sub-Investigator: Franz Keller, Dr. med.            
Sub-Investigator: Anna Schmitz, Dr. med.            
Sub-Investigator: Martin Blay, Dr. med.            
Sponsors and Collaborators
Kantonsspital Münsterlingen
Investigators
Principal Investigator: Michael Schueler, Dr. med. Chief of the department for orthopedic surgery Kantonsspital Münsterlingen, Schweiz
  More Information

No publications provided

Responsible Party: Kantonsspital Münsterlingen
ClinicalTrials.gov Identifier: NCT01135160     History of Changes
Other Study ID Numbers: KSM 2010-1
Study First Received: March 16, 2010
Last Updated: February 6, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kantonsspital Münsterlingen:
weight bearing
pain
total hip arthroplasty
total knee arthroplasty
weight bearing after TKA or THA

ClinicalTrials.gov processed this record on June 18, 2013