Arthropathy of HipNCT01135160
Evaluation of Weight Bearing After Total Hip and Knee Replacement
An observational study of Arthropathy of Hip and Arthropathy of Knee, run by Kantonsspital Münsterlingen at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthropathy of Hip, Arthropathy of Knee
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients receiving TKA or THA at our institution between August 2010 and August 2011
Who may be able to join
- 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
Who cannot join
- not able to walk on crutches
- not able to understand our recommendations
- other deformities of lower limbs
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Münsterlingen
Münsterlingen, Thurgau, 8596
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TKA/THA | All patients receiving TKA/THA meeting inclusion but not exclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startNov 2014
- Primary completionDec 2020
- Study completionDec 2022
Why it stopped: The planned number of patients was achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Münsterlingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Schueler, Dr. med., Principal investigator, Chief of the department for orthopedic surgery Kantonsspital Münsterlingen, Schweiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135160
- Sponsor's protocol ID
- KSM 2010-1
- Status last verified
- Oct 2024
- First submitted
- 16 Mar 2010
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Weight Bearing in Patients After Total Hip and Knee Replacement
- ClinicalTrials.gov ID
- NCT01135160
- Acronym / sponsor ID
- KSM 2010-1
- Conditions
- Arthropathy of Hip, Arthropathy of Knee
- Keywords
- weight bearing, pain, total hip arthroplasty, total knee arthroplasty, weight bearing after TKA or THA
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The planned number of patients was achieved.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kantonsspital MünsterlingenUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKA/THA | – | –All patients receiving TKA/THA meeting inclusion but not exclusion criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients receiving TKA or THA at our institution between August 2010 and August 2011
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- not able to walk on crutches
- not able to understand our recommendations
- other deformities of lower limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
pain under partial weight bearing (recommended)
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: The planned number of patients was achieved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Schueler, Dr. med. principal investigator
Chief of the department for orthopedic surgery Kantonsspital Münsterlingen, Schweiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy of Hip and Arthropathy of Knee, run by Kantonsspital Münsterlingen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The planned number of patients was achieved.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
full weight bearing allowed and accomplished end of 6th week (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.