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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04418687
Other study ID # IRAS 235931
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 28, 2018
Est. completion date March 31, 2020

Study information

Verified date June 2020
Source University of Central Lancashire
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Total knee replacements are a common orthopaedic procedure undertaken at Blackpool Victoria Hospital. Following surgery patients are routinely seen by Physiotherapists who prescribe exercises to improve the range of movement and strength of the knee joint, thus aiding recovery. One of the key exercises prescribed involves the bending and straightening of the knee to improve range of movement. At this early stage of rehabilitation , due to weakness in the knee joint, reducing any resistance to this motion is beneficial. The Orthoglide device is designed to aid the patient in performing this movement by reducing the friction/resistance caused by the heel sliding against the bed. Currently this is achieved using a 'slider board' and placing a rolled up piece of fabric under the patients heel. The aim of this study is to investigate whether or not issuing an Orthoglide device to patients following total knee replacements improves functional outcomes reported by the patient at 6 weeks and 12 weeks post-surgery. Participants will be assigned to either receive an Orthoglide device and standard Physiotherapy or standard Physiotherapy alone. A series of patient reported outcome measures will be taken pre-surgery, 6 weeks post surgery and 12 weeks post surgery and the results compared.


Description:

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Study Design


Intervention

Device:
Orthoglide
Knee rehabilitation device.
Other:
Physiotherapy only
Physiotherapy only.

Locations

Country Name City State
United Kingdom Blackpool Victoria Hospital Blackpool Lancashire

Sponsors (2)

Lead Sponsor Collaborator
Ambreen Chohan Blackpool Victoria Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Knee Osteoarthritis Outcome Score (KOOS) Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. A better score would be indicated by a higher number closer to 100. Change from Baseline to 6 and 12 weeks
Secondary Change in Numerical Pain Rating Score (NPRS) Scored from 0 to 10. Higher scores (closer to 10) indicate a higher level of pain and lower numbers indicate less pain. A minimal clinically important change in NPRS is a 2 point improvement. Change from Baseline to 6 and 12 weeks
Secondary Change in Exercise Adherence Rating Scale EARS consists of 6 questions scored on a 5-point Likert scale, with positively worded questions reverse scored, giving a final rating from 0 (lowest adherence) to 24 (highest adherence). Better adherence is sought with any intervention Change from Baseline to 6 and 12 weeks
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