A prospective imaging study of cruciate retaining and substituting knee replacement, in osteoarthritis and healthy aging - the PICKLeS study

Not Applicable

Completed

• Conditions: Knee osteoarthritis, awaiting total knee replacement; Musculoskeletal Diseases; Other arthritis

• Registration Number: ISRCTN75076749
• Lead Sponsor: Canberra Hospital (Australia)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30690574 (added 22/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-18
• Study Completion: 2014-12-30
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Total knee replacement group:
1.1. Participant is awaiting total knee replacement
1.2. The surgeon agrees that either a posterior-cruciate-retaining (PCR) or posterior stabilized (PS) knee is equally suitable for this participant
1.3. Participant has osteoarthritis of the knee
1.4. Participant is able to come back for 12 month follow up
1.5. Participant is aged 40 ? 80 years
2. Healthy age-matched control group:
2.1. Participant is age-matched to a participant in total knee replacement (TKR) group
2.2. Participant has no history of injury or osteoarthritis in either knee
2.3. Participant has no pain in either knee
3. Healthy aging group:
3.1. Participant is aged 20-30, 40? 50, 60? 70, or 80+ years
3.2. Participant has no history of injury or osteoarthritis in either knee
3.3. Participant has no pain in either knee

Exclusion Criteria

1. Total knee replacement group:
1.1. Lateral compartment osteoarthritis only.
1.2. Body mass index (BMI) > 38
1.3. UCLA score of = 2
1.4. Knee flexion < 90º
1.5. Fixed flexion contracture of = 10º
1.6. A psychosocial reason not be able to consent or complete the requirements of the study
1.7. Metastatic disease
1.8. Pathological fracture
1.9. Revision knee replacement
1.10. Poor understanding and is unable to provide informed consent
1.11. Pregnant
2. A healthy age-matched control group participant or a healthy aging group participant:
2.1. Age under 20 years
2.2. History of injury or osteoarthritis in either knee
2.3. Pain in either knee
2.4. Clinically reduced score on oxford knee score
2.5. Clinical examination demonstrates pain, loss of range of motion, injury or osteoarthritis
2.6. X- rays demonstrate injury or ostearthritis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Knee kinematics are measured by mapping the tibiofemoral contact pattern, that is defined as the centroid of contact of the femoral condyles on the tibial plateau, while three knee activities:<br> 1. A step up<br> 2. Rising from sitting<br> 3. A squat to flex the knee from 0º to the participant?s point of full flexion<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Knee kinematic analysis by measurement of orthogonal motion in 6 degrees of freedom (3 translations and 3 rotations)<br> 2. Functional tests: Timed Up-and-Go, 6-minute walk test, chair rising x 5 test. Knee Range of Motion<br> 3. Knee Society Score<br> 4. Oxford knee score<br> 5. Patient satisfaction<br> 6. Pain visual analogue measure<br>