Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07914036
NA

Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

Total knee arthroplasty (TKA) remains the definitive treatment for advanced knee osteoarthritis and continues to be performed with increasing frequency worldwide. However, patient dissatisfaction remains reported in up to one-fifth of cases, despite technically successful procedures and acceptable radiographic results. This discrepancy has shifted attention toward early functional recovery and patient-reported outcomes as more meaningful indicators of success. In response, technological innovations such as robotic-assisted total knee arthroplasty have been introduced to enhance surgical precision and reduce alignment outliers. This study aims to determine whether these technical advantages translate into improved early clinical outcomes by comparing patient satisfaction, functional results, radiological accuracy, and perioperative parameters between robotic-assisted and conventional total knee arthroplasty over one year.

Official title: Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-10-30

Completion Date

2028-04-30

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DEVICE

Mako4 Robotic Arm Assisted Total Knee Arthroplasty

All patients will be managed by the same surgical team , performed with the patient in supine position. Prophylactic intravenous antibiotics will be administered 30 minutes before skin incision , using weight-adjusted dosing. An above-knee pneumatic tourniquet will be applied in all cases, and a standard medial parapatellar approach will be used. Patients allocated to the robotic-assisted group will undergo total knee arthroplasty using the Mako Robotic-Arm Assisted System (Stryker, Kalamazoo, Michigan, USA) with the Triathlon Total Knee System. Robotic assistance will be used for preoperative/intraoperative surgical planning, bone preparation, component positioning, and intraoperative assessment of soft-tissue balance. In both groups, all components will be implanted using cemented fixation. Stem extensions may be used selectively on a case-by-case basis.The patella will be managed with conventional patelloplasty in all patients. Closed-suction drains will be used routinely.

PROCEDURE

conventional total knee arthroplasty using Triathlon Total Knee System

All patients will be managed by the same surgical team , performed with the patient in supine position. Prophylactic intravenous antibiotics will be administered 30 minutes before skin incision , using weight-adjusted dosing. An above-knee pneumatic tourniquet will be applied in all cases, and a standard medial parapatellar approach will be used. Patients allocated to the conventional (control) group will undergo total knee arthroplasty using the Triathlon Total Knee System (Stryker, Kalamazoo, Michigan, USA) with standard manual instrumentation and conventional cutting jigs, without robotic assistance. Component sizing, bone preparation, positioning, and soft-tissue balancing will be performed using standard conventional techniques. All components will be implanted using cemented fixation. Stem extensions may be used selectively on a case-by-case basis. The patella will be managed with conventional patelloplasty in all patients. Closed-suction drains will be used routinely.

Locations (1)

Ainshams university

Cairo, Egypt