Posterior cruciate ligament and total knee arthroplasty: retain, sacrifice or substitute? A prospective, randomised clinical trial

Completed

• Conditions: Severe knee osteoarthritis; Musculoskeletal Diseases; Arthropathies

• Registration Number: ISRCTN82612978
• Lead Sponsor: Helsinki University Central Hospital (Finland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-12
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 285

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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<br>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<br>3. Difference in the observed change in the quality of life, measured at 2, 5 and 10 years<br>4. Difference in the Oxford Knee questionnaire, measured at 2, 5 and 10 years