Changes of Pressure on Soft Tissue Before and After Total Hip Replacement to Prevent Bedsores

NCT ID: NCT02163200

Last Updated: 2016-03-29

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-10-31

Brief Summary

Patients candidates for total hip replacement are, generally elderlies and have hip pain, we will check if the pressure to the soft tissue changes before and after operation using a tapet with pressure sensors sending the information to specific software.

Detailed Description

one hundred Patients 60 years old and more will be considered for this study, both sexs, that have schedule for elective unilateral total hip replacement and have not bedsores previously.

All the data will be collected by FSA software, classified in an excel table. A crossover study will be performed and analyzed by a paired test.

Conditions

Transient Arthropathy of Hip

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

pressure of total hip replacement

Patients 60 y.o. or more both sex with a history of hip arthropathy without previous bedsores or CVA

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Both sexes
• Schedule for total hip replacement

Exclusion Criteria

• Patient with previous bedsore
• Patients under 60 y.0.
• Previous CVA

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assuta Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sergio Gabriel Susmallian

Head of the Department of General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergio G Susmallian, MD

Role: STUDY_DIRECTOR

Assuta MC

Other Identifiers

0906-14

Identifier Type: -

Identifier Source: org_study_id