Evaluation of Weight Bearing After Total Hip and Knee Replacement

August 7, 2018 updated by: Kantonsspital Münsterlingen

Evaluation of Weight Bearing in Patients After Total Hip and Knee Replacement

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Thurgau
      • Münsterlingen, Thurgau, Switzerland, 8596
        • Recruiting
        • Kantonsspital Münsterlingen
        • Contact:
        • Principal Investigator:
          • Michael Schueler, Dr. med.
        • Sub-Investigator:
          • Martin Blay, Dr. med.
        • Sub-Investigator:
          • Lars Edelman
        • Sub-Investigator:
          • Jaqueline Fust, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
TKA/THA
All patients receiving TKA/THA meeting inclusion but not exclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Münsterlingen

Investigators

  • Principal Investigator: Michael Schueler, Dr. med., Chief of the department for orthopedic surgery Kantonsspital Münsterlingen, Schweiz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 16, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSM 2010-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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