Condition category
Musculoskeletal Diseases
Date applied
11/05/2007
Date assigned
12/09/2007
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

http://www.hus.fi/

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

government non-federal

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/03/2016: Plain English summary added.