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TerminatedNCT01135160Updated Oct 18, 2024

Evaluation of Weight Bearing After Total Hip and Knee Replacement

An observational study in Arthropathy of Hip and Arthropathy of Knee, sponsored by Kantonsspital Münsterlingen. Terminated at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2024-10-18.

Sponsored by Kantonsspital Münsterlingen · Observational

Why this study was terminated
The planned number of patients was achieved.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study 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.

02

Conditions studied

  • Arthropathy of Hip
  • Arthropathy of Knee

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Keywords

  • weight bearing
  • pain
  • total hip arthroplasty
  • total knee arthroplasty
  • weight bearing after TKA or THA
03

In context

Joint Diseases

712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 216 observational studies indexed under Joint Diseases.

Browse Joint Diseases studies →

Lead sponsor

Kantonsspital Münsterlingen is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

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

Exclusion Criteria:

  • not able to walk on crutches
  • not able to understand our recommendations
  • other deformities of lower limbs
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)

Groups and cohorts

  • TKA/THA

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

06

What researchers measure

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

    Time frame: 6 weeks

Secondary outcomes

  1. 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.

    Time frame: 6 weeks

07

Study locations

1 site
  • Kantonsspital Münsterlingen
    Münsterlingen, Thurgau 8596, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01135160
Lead sponsor
Kantonsspital Münsterlingen
Responsible party
Sponsor
First posted
Jun 2, 2010
Start date
Nov 2014
Primary completion
Dec 2020
Completion
Dec 2022
Last update
Oct 18, 2024

Study contacts

Michael Schueler, Dr. med.
principal investigator · Chief of the department for orthopedic surgery Kantonsspital Münsterlingen, Schweiz

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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