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Comparative study between conventional and patient-specific instrument in total knee arthroplasty

Comparison of Clinical and Radiological Results with respect to Surgical Technique (Conventional and Patient-Specific Instrument Total Knee Arthroplasty ) : Randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005276
Enrollment
104
Registered
2020-08-04
Start date
2020-08-07
Completion date
Unknown
Last updated
2020-10-05

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

Conditions

None listed

Interventions

Procedure/Surgery : 1) Research Method Overview We will perform total knee arthroplasty and compare the results by dividing the group into a group that will perform patient-specific surgical procedu

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Subjects who are undergoing total knee arthroplasty for one or both knees due to primary knee degenerative arthritis between 55 and 85 years of age. Year) -Kellgre-Lawrence grade (0-4, 5 stage) grade 0: no radiographic features of osteoarthritis grade 1: Radiological findings suggest that the joint gap is slightly narrowed and bone projections are suspected Grade 2: The radiological findings show a narrow joint gap and clearly visible bone protrusions. Grade 3: Radiological findings show that the joint gap is narrow, several bone protrusions are visible, bone deformity is visible, and bone sclerosis is visible. Grade 4: Radiological findings show that the joint gap is clearly narrowed, large bone protrusions are observed, severe bone sclerosis and clear bone deformity are observed. -Subjects who have fully explained the preoperative study and expressed their intention to participate

Exclusion criteria

Exclusion criteria: -Subjects diagnosed with inflammatory arthritis (rheumatic arthritis, psoriatic arthritis, spondylosis, etc.) -Subjects with post-traumatic arthritis in the knee due to surgery -Subjects with arthritis due to bone necrosis in the knee due to surgery -A person with a history of infectious arthritis in the knee joint due to surgery -Subjects with reduced range of motion of the knee joint (more than 20 degrees of flexion construction and less than 90 degrees of subsequent flexion) -Subjects with very severe valgus and varus deformity (Hip-Knee-Ankle angle ± 15 degrees or more) -When the destruction and deformation of the joint is severe, it is expected to perform artificial joints using bone grafts, blocks, and long poles. -Subjects who are deemed to have an impact on the analysis of results due to severe deformation of the femur, tibia and patella including around the knee joint -If it is judged that it is not appropriate to be included in the study by other responsible researchers

Design outcomes

Primary

MeasureTime frame
Outlier portion with Hip-Knee-Ankle angle greater than 3 degrees

Secondary

MeasureTime frame
alpha/beta/gamma/delta angle;WOMAC score;KSS score;VAS score;Subjective satisfaction;Estimated Blood Loss;Operation time;Range of motion;Tourniquet time

Countries

Korea, Republic of

Contacts

Public ContactDo Weon Lee

Seoul National University Hospital

Outcome results

None listed

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