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Clinical Trials/NCT01976897
NCT01976897
Completed
N/A

Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface

Centre Hospitalier Universitaire de Nīmes1 site in 1 country65 target enrollmentMarch 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Adult, Hospitalized
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
65
Locations
1
Primary Endpoint
Measurement 1: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks).
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The main objective of this study is to evaluate the relationship between the angle of knee flexion in a supine position with joint relaxation (DDPD) and the maximum interface pressure at the heel area (PtAl).

Detailed Description

The secondary objectives of this study are: A. To evaluate the relationship between the angle of flexion of the knee in DDPD and the average pressure throughout the heel area (Pmean). B. To evaluate the relationship between the angle of flexion of the knee in DDPD and the contact surface of the heel area (Stal) where the pressure is greater than 60 mm Hg. C. To evaluate the inter-operator concordance for the knee flexion angle measurement in DDPD via photos. D. To evaluate the inter-operator concordance for skin marks used to measure knee flexion angles in DDPD via photos (only one knee for 30 patients). E. To evaluate the inta-operator concordance (measures on 2 consecutive days) for skin marks used to measure knee flexion angles in DDPD via photos (for 30 patients).

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
May 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is in a stable medical state (no complications within the past 10 days)

Exclusion Criteria

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient has had medical complications within the ten days preceding study inclusion
  • The patient has a bed-sore or bandages on his/her heels
  • The patient has had a lower-limb amputation

Outcomes

Primary Outcomes

Measurement 1: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks).

Time Frame: Day 0

Measurement 2: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks)

Time Frame: Day 0

Maximum pressure on the heel area (Ptal)

Time Frame: Day 0

Secondary Outcomes

  • Mean pressure over the entire heel area (P mean)(Day 0)
  • Measurement of the contact surface of the heel zone (Stal) having a pressure greater than 60 mmHg(Day 0)
  • Concordance for measurements 1 & 2 for knee flexion angle in a relaxed supine position (via photos)(Day 0)
  • Concordance for skin marks for knee flexion angles between 2 operators for 30 knees.(Day 0)
  • Intra-operator concordance for skin marks used for measuring knee flexion angle for 30 knees(Day 1)

Study Sites (1)

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