Evaluation of Weight Bearing After Total Hip and Knee Replacement

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2016 by Kantonsspital Münsterlingen

Sponsor:

Information provided by (Responsible Party):

Kantonsspital Münsterlingen

ClinicalTrials.gov Identifier:

NCT01135160

First received: March 16, 2010

Last updated: August 30, 2016

Last verified: August 2016

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
Arthropathy of Hip Arthropathy of Knee


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:

MedlinePlus related topics: Body Weight Knee Replacement

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:	100
Study Start Date:	November 2014
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts
TKA/THA All patients receiving TKA/THA meeting inclusion but not exclusion criteria

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts


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

Locations


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.

Sponsors and Collaborators

Kantonsspital Münsterlingen

Investigators


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

More Information


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:	August 30, 2016
Health Authority:	Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on September 23, 2016

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