Mako Functionally Aligned Total Knee Arthroplasty vs Mako Mechanically Aligned Total Knee Arthroplasty

NCT04092153 | Completed FDA Device

• 1 other identifier: 17/0721
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates outcomes of robotic-arm assisted mechanically aligned total knee arthroplasty \[MA TKA\] versus robotic-arm assisted functionally aligned total knee arthroplasty \[FA TKA\]. Half the study will receive MA TKA and half will receive FA TKA.

Conditions

Osteo Arthritis Knee; Osteoarthritis; Surgery

Keywords

total knee arthroplasty; total knee replacement; functional alignment; kinematic alignment; robotic surgery; mako robot; makoplasty; patient outcomes

Outcome Measures

Primary Outcomes (1)

• Western Ontario and Mcmaster Universities Arthritis Index (WOMAC)

  Patient recorded outcome questionnaire evaluating pain, stiffness and disability in affected joint

  2 years post-intervention

Secondary Outcomes (15)

• Lower limb alignment

  pre op and 6 weeks post op

• Operating time

  interoperative

• Time to discharge

  Documented when participant leaves hospital, an average of 72 -96 hours

• Forgotten Joint Score (FJS)

  Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

• Oxford Knee Score (OKS)

  Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

Study Arms (2)

Mechanically aligned

ACTIVE COMPARATOR

Neutral limb alignment irrespective of the patient's native knee anatomy and joint mechanics

Device: Total knee arthroplasy

Functionally aligned

EXPERIMENTAL

Restore the patient's own pre-arthritic knee anatomy

Device: Total knee arthroplasy

Interventions

Total knee arthroplasy DEVICE

Surgical implantation of prosthetic knee using robotic-arm assist

Functionally aligned; Mechanically aligned

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has symptomatic knee osteoarthritis requiring primary TKA
• Patient and surgeon are in agreement that TKA is the most appropriate treatment
• Patient is fit for surgical intervention following review by surgeon and anaesthetist
• Patient is between 18-80 years of age at time of surgery
• Gender: male and female
• Patient must be capable of giving informed consent and agree to comply with the postoperative review program
• Patient must be a permanent resident in an area accessible to the study site
• Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken

You may not qualify if:

• Patient is not suitable for routine primary TKA e.g. patient has ligament deficiency that requires a constrained prosthesis
• Patient has bone loss that requires augmentation
• Patient is not medically fit for surgical intervention
• Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA
• Patient is immobile or has another neurological condition affecting musculoskeletal function
• Patient is less than 18 years of age or greater than 80 years of age
• Patient is already enrolled on another concurrent clinical trial
• Patient is unable or unwilling to sign the informed consent form specific to this study
• Patient is unable to attend the follow-up programme
• Patient is non-resident in local area or expected to leave the catchment area postoperatively

Sponsors & Collaborators

• University College, London: lead
• Stryker Orthopaedics: collaborator

Study Sites (1)

University College London Hospital NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

Related Publications (1)

• Kayani B, Konan S, Tahmassebi J, Oussedik S, Moriarty PD, Haddad FS. A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty. Trials. 2020 Feb 18;21(1):194. doi: 10.1186/s13063-020-4123-8.

  PMID: 32070406 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Fares S Haddad

  UCLH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: December 28, 2018
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)