Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)

Ewha Womans University

Status and phase: Completed; Phase 4

Conditions: Robotics; Arthritis; Knee Arthropathy

Treatments: Procedure: Conventional TKA; Procedure: Robotic-assisted TKA

Study type: Interventional

Funder types: Other

Identifiers

NCT03659318

RoboTKA

Details and patient eligibility

About

Robotic-assisted total knee arthroplasty (TKA) was introduced to attempt to enhance the precision of bone preparation, component alignment and ultimately improve clinical results and survivorship of TKA. Although several published data suggest that bone preparation, and knee component alignment were improved by using robotic assistance, there is no high-quality evidence from randomized trials at long-term of which investigators are aware evaluating whether the improved bone preparation and knee component alignment improved clinical function or longevity of the TKA.

Full description

Robotic-assisted TKA was introduced in an attempt to enhance component alignment and to improve long-term clinical results and implant durability, particularly in younger patients. Several comparative studies of conventional and robotic-assisted TKAs demonstrated that improved alignment of the components was obtained after the robotic-assisted TKAs than conventional TKAs.

To date, however, no comprehensive synthesis of long-term randomized data has been conducted specifically for robotic-assisted TKA, particularly in younger patients. It is crucial to determine whether improved alignment of the TKA components obtained by using robotic-assistance, would improve better long-term and functional results and survivorship of TKAs.

The aims of the current study were to examine the two groups of patients after long-term follow-up to determine whether the clinical results, radiographic and CT scan results, and the survivorship of TKA would be better after robotic-assisted TKA than after conventional TKA.

Enrollment: 674 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• end stage knee arthritis

Exclusion criteria

• mild knee deformity
• inflammatory arthritis
• foot and ankle disorder
• dementia
• hip disease
• history of a stroke
• older than 65 years of age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

674 participants in 2 patient groups

Robot

Experimental group

Description:

TKA is done with robotic-assisted manner. Final implantation of implants is done by surgeons, same as the conventional way. Robotic-assisted TKA for this arm.

Treatment:

Procedure: Robotic-assisted TKA

Conventional

Active Comparator group

Description:

TKA is done with conventional instruments. Conventional TKA for this arm.

Treatment:

Procedure: Conventional TKA