Study Detail


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Gait Cycle Analysis after Total Knee Replacement

Short Study Title:
Gait Cycle Analysis after Total Knee Replacement

Protocol No.
1

Description:
Investigation into the kinematics and kinetics of a controlled group after total knee replacement with the Physica KR (Kinematic Retaining) Design during walking, running and turning activities.

REC reference:
15/SC/0725

Sponsor(s):
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

IRAS Project ID:
172937

Funder(s):
Bournemouth University

Geographical Scope:
Multicentre - National

Disease Area:
Total knee replacements

Sample Size:
30

Study Type:
Observational

Study Design:
Non randomised

Estimated Closure Date:
30/11/2017

Current Status:
Not yet recruiting

Inclusion Criteria:

Total Knee Replacement Participants:
Patients enrolled in the Physica KR follow-up clinical study according to all inclusion criteria. (K-06- Study protocol 30/10/2013 v 1.0 approved by the Health Research Authority NRES Committee East of England - Cambridge East on February 13th 2014 and by the R&D Department of The Royal Bournemouth and Christchurch Hospital NHS Foundation Trust on March 7th 2014).
Patients received a TKR with Physica KR knee prosthesis for primary OA.
A minimum follow-up of 12 months and maximum of 16 months after the surgery.
Patients who had normal or intense daily activity level before the surgery.
Age 22-75 years.
Patients achieving a minimum knee Society Score of 70 at the 12-month follow-up stage.
No flexion contracture on the replaced knee.
Patients able to perform the movements unassisted for the gait testing session.
Asymptomatic in the contralateral and ipsilateral lower limbs (hip, knee and ankle).
No previous surgery on the contralateral side.
Patients who have signed the informed consent.

Control Participants:
Age 22-75 years.
Participants with normal or intense daily activity level.
Asymptomatic in lower limbs (hip, knee and ankle).
No previous surgery on their lower limbs.

Exclusion Criteria:

Total Knee Replacement Participants:
Patients excluded from the Physica KR follow-up clinical study, according to exclusion criteria (K-06- Study protocol 30/10/2013 v 1.0 approved by the Health Research Authority NRES Committee East of England - Cambridge East on February 13th 2014 and by the R&D Department of The Royal Bournemouth and Christchurch Hospital NHS Foundation Trust on March 7th 2014).
Obese patients with BMI above 35 Kg/m2.
Unable to perform the movements being assessed unassisted for gait testing session.
Patients with musculoskeletal or neurological disorders that have an effect on gait.
Patients unable to understand the details and the nature of the study.
Patients with previous surgery on the contralateral side.
Unable to give informed consent.
Patients who experience back pain.

Control Participants:
Unable to perform the movements unassisted for gait testing session.
Participants with musculoskeletal or neurological disorders that have an effect on gait.
Unable to give informed consent.
Participants who experience back pain.

Chief Investigator:
Miss Elizabeth J Craig
Bournemouth University

Key Co-Investigator(s):
Professor Siamak Noroozi
Bournemouth University

Dr Philip Sewell
Bournemouth University

Mr Adrian Harvey
Royal Bournemouth Hospital

Location(s):
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Southampton Solent University