Evaluation of Weight Bearing After Total Hip and Knee Replacement

Arthropathy of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01135160
• Other study ID #: KSM 2010-1
• Status: Recruiting
• Start date: November 2014
• Est. completion date: December 2022

Study information

• Verified date: November 2017
• Source: Kantonsspital Münsterlingen
• Contact: Martin Blay, Dr. med.
• Phone: +41-71-686-2030
• Email: martin.blay[@]stgag.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Hip
• Arthropathy of Knee
• Joint Diseases

Locations

Country	Name	City	State
Switzerland	Kantonsspital Münsterlingen	Münsterlingen	Thurgau

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Münsterlingen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	full weight bearing allowed and accomplished end of 6th week	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	pain under partial weight bearing (recommended)	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