A Prospective Randomised Trial comparing Post-operative knee alignment following total knee replacement using patient specific knee instrumentation based on either CT or MRI.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202009612835052

Enrollment

Registered

2020-09-25

Start date

2017-05-29

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Musculoskeletal Diseases

Interventions

CT PSI

MRI PSI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients suitable for primary Total Knee Replacement 2. Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of: a. Osteoarthritis b. Avascular necrosis c. Inflammatory Arthritis d. Traumatic arthritis 3. Patients aged over 18 and up to 80 years of age 4. Patients with limited co-morbidity – ASA I – III 5. Patients must be able to understand instructions and be willing to return for follow-up

Exclusion criteria

Exclusion criteria: 1. Patients with significant co-morbidity - ASA IV - V 2. Dementia and inability to understand and follow instructions 3. Neurological conditions affecting moment 4. Patients who are intolerant of placement in a CT or MRI gantry because of claustrophobia.

Design outcomes

Primary

Measure	Time frame
Coronal and sagittal knee alignment following total knee replacement using PSI based on either CT scan or MRI.	—

Secondary

Measure	Time frame
1. Oxford Knee Score at each post-operative visit. 2. Knee Society Score pre and post-operatively. 3. Knee injury and Osteoarthritis Outcome Score (KOOS). 4. Radiographic analysis at each post-operative visit. 5. Complications (including revisions/removals). 6. Clinical Composite Success	—

Countries

South Africa

Contacts

Public ContactAnna Grisillo Biscardi Biscardi

Trial Coordinator

Anna.Grisillo@wits.ac.za+27117172538

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026