Mako Cementless TKA vs Mako Cemented TKA

NCT06929871 | Recruiting

• 1 other identifier: 151407
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aims of this prospective, randomised, single-blinded controlled trial are to compare functional, radiological and clinical outcomes in Mako robotic-arm assisted cementless Total Knee Arthroplasty (TKA) versus Mako robotic-arm assisted cemented TKA.

Conditions

Total Knee Replacement; Total Knee Replacement Surgery; Total Knee Arthroplasty; Osteoarthritis (OA) of the Knee

Keywords

robotic surgery; cemented implants; uncemented implants; makoplasty; functional outcomes; clinical outcomes; radiological outcomes; inflammatory marker; radiostereometric analysis; RSA

Outcome Measures

Primary Outcomes (1)

• The Forgotten Joint Score [FJS]

  The Forgotten Joint Score (FJS) is a patient-reported outcome measure (PROM) used to assess the degree to which patients have "forgotten" their artificial joint, particularly after joint replacement surgery, like knee replacements. The score \[100 is best\] was developed to measure the success of a joint replacement by evaluating how well a patient has adjusted to the implanted joint in their daily life. It aims to show whether the patient feels like the artificial joint is part of their body and doesn't think about it in normal activities. The FJS has a series of questions about: * Pain or discomfort in the joint * Function and mobility * The awareness of the joint during daily activities (e.g., walking, climbing stairs, or sitting) * The patient's satisfaction with the joint. A high score means the patient feels that the joint replacement is functioning well and does not interfere with their quality of life, while a lower score may indicate that the patient is not fully satisfied.

  At one year post-op

Secondary Outcomes (24)

• Assessement of tibial implant migration by maximum total point motion [MTPM] in millimetres using Radiostereometric analysis (RSA)

  1, 2 and 5-years post-op

• Assess risk of loosening of the knee prosthesis by maximum total point motion [MTPM] in millimetres using Radiostereometric analysis [RSA]

  1, 2 and 5-years post-op

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Preoperatively and postoperatively at 1 year, 2 years and 5 years

• The Oxford Knee Score (OKS)

  Preoperatively and postoperatively at 1 year, 2 years and 5 years

• European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)

  1, 2 and 5-years post-op

Study Arms (2)

Mako cementless TKA

EXPERIMENTAL

Mako robotic-arm assisted total knee arthroplasty using cementless implants

Device: Mako cementless TKA

Mako cemented TKA

ACTIVE COMPARATOR

Mako robotic-arm assisted total knee arthroplasty using cemented implants

Device: Mako cemented TKA

Interventions

Mako cementless TKA DEVICE

Mako robotic-arm assisted total knee arthroplasty using cementless implants

Mako cementless TKA

Mako cemented TKA DEVICE

Mako robotic-arm assisted total knee arthroplasty using cemented implants

Mako cemented TKA

Eligibility Criteria

• Age: 18 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 over 18 years old 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 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 has a DEXA scan with T-score \< -2.5 at any point
• Patient is immobile or has another neurological condition affecting musculoskeletal function
• Patient is less than 18 years at time of surgery
• Patient is unable or unwilling to sign the informed consent form specific to this study
• Patient is unable to attend the follow-up programme
• Previous pathological fracture

Sponsors & Collaborators

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

Study Sites (1)

UCL Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Fares S Haddad, MBBS MD (Res) MCh (Orth) FRCS

  UCL Hospitals NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Jenni Tahmassebi, BSc MSc

CONTACT

+442034479403; jenni.tahmassebi1@nhs.net

Study Design

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

Model Details: prospective, randomised, single-site, single-blinded trial

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 16, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): August 1, 2031
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)