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

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ClinicalTrials.gov Identifier: NCT02163200
Recruitment Status : Withdrawn (due to technical issues)
First Posted : June 13, 2014
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Sergio Gabriel Susmallian, Assuta Medical Center

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.

Condition or disease
Transient Arthropathy of Hip

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Changes of Pressure on Soft Tissue Before and After Total Hip Replacement to Prevent Bedsores
Study Start Date : June 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Group/Cohort
pressure of total hip replacement
Patients 60 y.o. or more both sex with a history of hip arthropathy without previous bedsores or CVA



Primary Outcome Measures :
  1. Changes in soft tissue pressure [ Time Frame: Day one ]
    Mapping of pressure will be performed twice for each patient' the first one before surgery the second one before discharge. The measure will be performed by resting, normal position



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient 60 y.o. or more both sexs, schedule for total hip replacement, without previous bedsore
Criteria

Inclusion Criteria: 60 y/o/ and more

  • Both sexes
  • Schedule for total hip replacement

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163200


Sponsors and Collaborators
Assuta Medical Center
Investigators
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Study Director: Sergio G Susmallian, MD Assuta MC

Additional Information:

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Responsible Party: Sergio Gabriel Susmallian, Head of the Department of General Surgery, Assuta Medical Center
ClinicalTrials.gov Identifier: NCT02163200     History of Changes
Other Study ID Numbers: 0906-14
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016

Keywords provided by Sergio Gabriel Susmallian, Assuta Medical Center:
Bedsores
pressure
hip

Additional relevant MeSH terms:
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Joint Diseases
Pressure Ulcer
Musculoskeletal Diseases
Skin Ulcer
Skin Diseases