Evaluation of Weight Bearing After Total Hip and Knee Replacement

NCT01135160 | Terminated DMC

• 1 other identifier: KSM 2010-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthropathy of Hip; Arthropathy of Knee

Keywords

weight bearing; pain; total hip arthroplasty; total knee arthroplasty; weight bearing after TKA or THA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• pain under partial weight bearing (recommended)

  6 weeks

Study Arms (1)

TKA/THA

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• not able to walk on crutches
• not able to understand our recommendations
• other deformities of lower limbs

Sponsors & Collaborators

• Kantonsspital Münsterlingen: lead

Study Sites (1)

Kantonsspital Münsterlingen

Münsterlingen, Thurgau, 8596, Switzerland

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Schueler, Dr. med.

  Chief of the department for orthopedic surgery Kantonsspital Münsterlingen, Schweiz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: June 2, 2010
• Study Start: November 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CH (1)