Posterior cruciate ligament and total knee arthroplasty: retain, sacrifice or substitute? A prospective, randomised clinical trial
| ISRCTN | ISRCTN82612978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82612978 |
| Secondary identifying numbers | TYH7306 |
- Submission date
- 11/05/2007
- Registration date
- 12/09/2007
- Last edited
- 18/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Helsinki University Central Hospital
Surgical Hospital
P.O. Box 263
00029 HUS
Helsinki
FIN-0009
Finland
| ville.remes@hus.fi |
Study information
| Study design | Prospective randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Posterior cruciate ligament and total knee arthroplasty: retain, sacrifice or substitute? A prospective, randomised clinical trial |
| Study objectives | 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(s) | Ethical committee of Surgical Department, Turku University Central Hospital, 02/05/2006, ref: TEKOHeKuTu2006/11032006 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 20/04/2006 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 285 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/04/2006 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- Finland
Study participating centre
FIN-0009
Finland
Sponsor information
Hospital/treatment centre
Surgical Hospital
P.O. Box 263
Helsinki
FIN-00029 HUS
Finland
| Website | http://www.hus.fi/ |
|---|---|
"ROR" |
https://ror.org/02e8hzf44 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- Helsinki University Central Hospital, HUS
- Location
- Finland
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/03/2016: Plain English summary added.
