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| [ Print-friendly version ] |
| A prospective imaging study of cruciate retaining and substituting knee replacement, in osteoarthritis and healthy aging - the PICKLeS study |
| ISRCTN | ISRCTN75076749 |
| ClinicalTrials.gov identifier | |
| Public title | A prospective imaging study of cruciate retaining and substituting knee replacement, in osteoarthritis and healthy aging - the PICKLeS study |
| Scientific title | A prospective imaging study of cruciate retaining and substituting knee replacement, in osteoarthritis and healthy aging: a randomised controlled trial |
| Acronym | PICKLeS |
| Serial number at source | PICKLeS Protocol v1_24_3_2011 |
| Study hypothesis |
Primary hypothesis:
1. A posterior stabilised knee implant design will provide better kinematics outcomes than a posterior cruciate retaining knee implant design for total knee replacement, in terms of tibiofemoral contact pattern and in terms of orthogonal motion of the femur and tibia Secondary hypotheses: 2. The kinematics of the knee pre-operatively with osteoarthritis determine the post operative kinematics 3. There is a powerful association between knee kinematics and measures of surgical success (KSS), functional outcomes and health related quality of life 4. The characteristics of healthy aging can be determined separately to the characteristics of osteoarthritis on knee kinematics |
| Lay summary | Lay summary under review |
| Ethics approval |
1. ACT Health Human Research Ethics Committee, ref: ETH 4-11-071
2. ACT Radiation Safety Council approved in May 2011 |
| Study design | Prospective (pre and post op) blinded randomised controlled trial |
| Countries of recruitment | Australia |
| Disease/condition/study domain | Knee osteoarthritis, awaiting total knee replacement |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/2012 |
| Anticipated end date | 30/12/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 40 participants in each of three groups, totalling 120 participants. |
| Interventions |
1. Total knee replacement group:
Participants are randomised to receive one of two knee replacements. A rotating bearing knee, retaining the posterior cruciate ligament, or a posterior stabilised knee that sacrifices the posterior cruciate ligament. 2. Healthy age-matched control group and healthy aging group - observational study only Knee kinematics is captured by image registration of a pre-operative computerised tomography (CT) scan of the knee to fluoroscopy of the knee while the participant completes various activities. This image registration provides a 3-dimensional model of the knee motion. Post operative knee kinematics is captured by registering the knee prosthesis computer design drawing, to the fluoroscopy images. |
| Primary outcome measure(s) |
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:
1. A step up 2. Rising from sitting 3. A squat to flex the knee from 0º to the participant’s point of full flexion |
| Secondary outcome measure(s) |
1. Knee kinematic analysis by measurement of orthogonal motion in 6 degrees of freedom (3 translations and 3 rotations)
2. Functional tests: Timed Up-and-Go, 6-minute walk test, chair rising x 5 test. Knee Range of Motion 3. Knee Society Score 4. Oxford knee score 5. Patient satisfaction 6. Pain visual analogue measure |
| Sources of funding | Canberra Hospital Private Practice Fund, Canberra (Australia) |
| Trial website | |
| Publications | |
| Contact name | Prof Paul Smith |
| Address |
Clinical Director of Orthopaedics
Trauma and Orthopaedic Research Unit Canberra Hospital Building 6, level 1 |
| City/town | Garran |
| Zip/Postcode | 2606 |
| Country | Australia |
| Sponsor | Canberra Hospital (Australia) |
| Address |
c/o Mr Lee Martin
Deputy Director ACT Health & General Manager Canberra Hospital Trauma and Orthopaedic Research Unit Building 6, Level 1 Yamba Drive |
| City/town | Garran |
| Zip/Postcode | 2606 |
| Country | Australia |
| Sponsor website: | http://www.canberrahospital.act.gov.au/ |
| Date applied | 07/10/2011 |
| Last edited | 18/11/2011 |
| Date ISRCTN assigned | 18/11/2011 |
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| © 2012 ISRCTN unless otherwise stated. | |
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