Plain English Summary
Background and study aims
Knee osteoarthritis is a condition where the cartilage inside the knee joint is worn away, leading to the bones rubbing against each other and becoming damaged. In knee replacement surgery, the damaged joint surface is removed and replaced with an implant. The posterior cruciate ligament is one of the four major ligaments of the knee. During knee replacement surgery the posterior cruciate ligament can either be kept in place, removed, or replaced with an implant. The aim of this study is to compare patient outcomes after total knee replacement surgery where the posterior cruciate ligament is retained, sacrificed or replaced.
Who can participate?
Patients aged 18 to 80 with primary osteoarthritis of the knee
What does the study involve?
Participants are randomly allocated to undergo knee replacement surgery where the posterior cruciate ligament is either be kept in place, removed, or replaced with an implant. Participants undergo walking tests and their knee function, osteoarthritis symptoms and quality of life are measured at 2, 5 and 10 years.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Helsinki University Central Hospital (Finland)
When is the study starting and how long is it expected to run for?
April 2006 to December 2018
Who is funding the study?
1. Helsinki University Central Hospital (Finland)
2. Orion-Farmos Research Foundation (Finland)
Who is the main contact?
Dr Ville Remes
ville.remes@hus.fi
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ville Remes
ORCID ID
Contact details
Helsinki University Central Hospital
Surgical Hospital
P.O. Box 263
00029 HUS
Helsinki
FIN-0009
Finland
-
ville.remes@hus.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TYH7306
Study information
Scientific title
Posterior cruciate ligament and total knee arthroplasty: retain, sacrifice or substitute? A prospective, randomised clinical trial
Acronym
Study hypothesis
To compare clinical, functional and radiological outcome after Total Knee Arthroplasty (TKA) between three different groups:
1. After Cruciate Retaining (CR) TKA and Posterior Cruciate Ligament (PCL) retained
2. After CR TKA and PCL sacrificed
3. After posterior stabilised TKA
Ethics approval
Ethical committee of Surgical Department, Turku University Central Hospital, 02/05/2006, ref: TEKOHeKuTu2006/11032006
Study design
Prospective randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Severe knee osteoarthritis
Intervention
1. Total Knee Arthroplasty (TKA) with Posterior Cruciate Ligament (PCL) retained
2. TKA with PCL excised, but not replaced
3. TKA with PCL excised and replaced with posterior stabilised implant
Follow-up will take place at 10 years.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
A 0.8 point (0.5 SD) difference in Total Knee Function Questionnaire and 15 mm difference in Visual Analogue Score (VAS) scale measuring subjective satisfaction, measured at 2, 5 and 10 years.
Secondary outcome measures
1. A difference of 15 points in the Western Ontario and McMasters Universities Osteoarthritic Index (WOMAC) questionnaire, converted to a scale of 0 to 100, measured at 2, 5 and 10 years
2. Difference in indicators of functional capacity (20-metre walking test and 3-metre "up and go" test), measured at 2, 5 and 10 years
3. Difference in the observed change in the quality of life, measured at 2, 5 and 10 years
4. Difference in the Oxford Knee questionnaire, measured at 2, 5 and 10 years
Overall trial start date
20/04/2006
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Primary osteoarthritis of the knee, planned to be treated by knee replacement surgery
2. Operation can be performed using condylar knee design
3. Collaterals are intact
4. Mechanical axis is at least one degree in varus
5. Aged 18 to 80 years
6. The patient's mother tongue is Finnish
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
285
Participant exclusion criteria
1. Patient has a secondary osteoarthritis of knee
2. The patient has undergone endoprosthetic surgery of the other knee or ankle in the preceding 12 months, or such a procedure is planned for the patient in the next 12 months
3. Simultaneous, one-stage knee arthroplasty
4. The patient has undergone surgery of the other knee, hip or ankle with an unsatisfactory outcome
5. The patient has been diagnosed with or is suspected to have an untreated or recurring malignancy or systemic infection
6. A disease treated with cortisone or immunosuppressive medication
7. The patient's cooperation is impaired for any reason
8. Any systemic disease that impairs the patient's mobility
9. Obesity, Body Mass Index (BMI) greater than 40
10. Female patients in fertile age who are planning to have children during the study
11. The patient has previously undergone an operation of the knee region other than arthroscopy or open menisectomy that extended below the subcutaneous tissue
12. The patient has a secondary knee osteoarthritis
13. Permanent patellar dislocation
14. Extra-articular deformity
15. Mechanical axis more than fifteen degrees on varus, neutral or in valgus
Recruitment start date
20/04/2006
Recruitment end date
31/12/2018
Locations
Countries of recruitment
Finland
Trial participating centre
Helsinki University Central Hospital
Helsinki
FIN-0009
Finland
Sponsor information
Organisation
Helsinki University Central Hospital (Finland)
Sponsor details
Surgical Hospital
P.O. Box 263
Helsinki
FIN-00029 HUS
Finland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Helsingin ja Uudenmaan Sairaanhoitopiiri
Alternative name(s)
Helsinki University Central Hospital, HUS
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Finland
Funder name
Orion-Farmos Research Foundation (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list