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

Completed

• Conditions: Adult, Hospitalized
• Interventions: Other: Knee flexion measurement 1; Other: Knee flexion measurement 2; Other: Heel - interface pressure measurements

• Registration Number: NCT01976897
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

Study Timeline

• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Study Start: 2014-03
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	Knee flexion measurement 1	Only one group is included. See inclusion/exclusion criteria. Intervention: Knee flexion measurement 1 Intervention: Knee flexion measurement 2 Intervention: Heel - interface pressure measurements
The study population	Knee flexion measurement 2	Only one group is included. See inclusion/exclusion criteria. Intervention: Knee flexion measurement 1 Intervention: Knee flexion measurement 2 Intervention: Heel - interface pressure measurements
The study population	Heel - interface pressure measurements	Only one group is included. See inclusion/exclusion criteria. Intervention: Knee flexion measurement 1 Intervention: Knee flexion measurement 2 Intervention: Heel - interface pressure measurements

Primary Outcome Measures

Name	Time	Method
Measurement 1: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks).	Day 0
Measurement 2: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks)	Day 0
Maximum pressure on the heel area (Ptal)	Day 0

Secondary Outcome Measures

Name	Time	Method
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	relaxed, decubitus dorsal position
Intra-operator concordance for skin marks used for measuring knee flexion angle for 30 knees	Day 1	Relaxed decubitus dorsal position

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France