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The early efficacy and safety of robotic-assisted restricted kinematic alignment versus mechanical alignment in total knee arthroplasty with Mako assistance:A randomized controlled study

The early efficacy and safety of robotic-assisted restricted kinematic alignment versus mechanical alignment in total knee arthroplasty with Mako assistance:A randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076118
Enrollment
Unknown
Registered
2023-09-25
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

knee osteoarthritis

Interventions

MA:mechanical alignment
rKA:restricted kinematic alignment

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Adult participants aged 18 to 80 years with knee osteoarthritis who underwent MAKO-assisted TKA. (2) Participants who require and tolerate the surgery as assessed by a physician. (3) Participants who are able to provide informed consent and agree to follow-up visits after the surgery. (4) Participants with sufficient mobility to participate in follow-up assessments.

Exclusion criteria

Exclusion criteria: (1) Participants undergoing revision surgery or stage 2 total knee arthroplasty. (2) Participants who are not suitable for the study prosthesis or have allergies to implant materials. (3) Participants with other neurological disorders affecting musculoskeletal function. (4) Participants who are currently enrolled in another concurrent clinical trial. (5) Participants with severe knee instability caused by incomplete collateral ligaments, cruciate ligaments, or posterior lateral structural damage. (6) Participants with rheumatoid arthritis accompanied by skin ulcers or a history of recurrent skin breakdown. (7) Participants with severe knee joint deformities: =20° of varus or valgus alignment.

Design outcomes

Primary

MeasureTime frame
WOMAC Index;

Secondary

MeasureTime frame
KSS index;FJS index;SF12 index;VAS score;ROM;HKA angle;

Countries

China

Contacts

Public ContactZijian Li

Peking University Third Hospital

doctorcjz@163.com+86 139 1129 0325

Outcome results

None listed

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