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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Recruitment Status : Withdrawn (due to technical issues)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

Tracking Information
First Submitted Date June 9, 2014
First Posted Date June 13, 2014
Last Update Posted Date March 29, 2016
Study Start Date June 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2014)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02163200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Changes of Pressure on Soft Tissue Before and After Total Hip Replacement to Prevent Bedsores
Official Title Changes of Pressure on Soft Tissue Before and After Total Hip Replacement to Prevent Bedsores
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration 4 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient 60 y.o. or more both sexs, schedule for total hip replacement, without previous bedsore
Condition Transient Arthropathy of Hip
Intervention Not Provided
Study Groups/Cohorts pressure of total hip replacement
Patients 60 y.o. or more both sex with a history of hip arthropathy without previous bedsores or CVA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: March 28, 2016)
0
Original Estimated Enrollment
 (submitted: June 11, 2014)
100
Estimated Study Completion Date October 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02163200
Other Study ID Numbers 0906-14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sergio Gabriel Susmallian, Assuta Medical Center
Study Sponsor Assuta Medical Center
Collaborators Not Provided
Investigators
Study Director: Sergio G Susmallian, MD Assuta MC
PRS Account Assuta Medical Center
Verification Date March 2016