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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82612978
Enrollment
285
Registered
2007-09-12
Start date
2006-04-20
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe knee osteoarthritis Musculoskeletal Diseases Arthropathies

Interventions

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 Foll

Sponsors

Helsinki University Central Hospital (Finland)
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026