Evaluation of Weight Bearing After Total Hip and Knee Rep... | NCT01135160

Studies
Evaluation of Weight Bearing After Total Hip and Knee Replacement

NCT01135160

Sponsor

Kantonsspital Münsterlingen

Status

Terminated

Last Update Posted

Oct 18, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Arthropathy of Hip
Arthropathy of Knee

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The planned number of patients was achieved.

Expanded Access Info

Start Date

Nov 2014Actual

Primary Completion Date

Dec 2020Actual

Completion Date

Dec 2022Actual

First Submitted Date

Mar 16, 2010

First Submission Date that Met QC Criteria

Jun 1, 2010

First Posted Date

Jun 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2024

Last Update Posted Date

Oct 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TKA/THA		All patients receiving TKA/THA meeting inclusion but not exclusion criteria

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Münsterlingen		Münsterlingen	Thurgau	8596	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided