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Search / Trial NCT06929871

Mako Cementless TKA vs Mako Cemented TKA

Launched by UNIVERSITY COLLEGE, LONDON · Apr 15, 2025

Trial Information

Current as of July 24, 2025

Not yet recruiting

Keywords

Robotic Surgery Cemented Implants Uncemented Implants Makoplasty Functional Outcomes Clinical Outcomes Radiological Outcomes Inflammatory Marker Radiostereometric Analysis Rsa

ClinConnect Summary

This clinical trial is looking at two different types of knee replacement surgeries: one that uses cement to secure the implant (called cemented TKA) and another that does not use cement (called cementless TKA). Both surgeries are assisted by a robot to help ensure precision during the procedure. The goal is to see which method leads to better results, including how well patients can move afterward and how their knees look on follow-up imaging.

To participate in this trial, individuals need to be over 18 years old and have knee osteoarthritis that makes surgery necessary. They must also agree with their surgeon that a total knee replacement is the best option for them and be healthy enough to undergo the surgery. Participants will receive post-surgery care and follow-ups to monitor their recovery and outcomes. Importantly, this study is not currently recruiting patients, so those interested will need to wait for recruitment to begin.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patient has symptomatic knee osteoarthritis requiring primary TKA
  • 2. Patient and surgeon are in agreement that TKA is the most appropriate treatment
  • 3. Patient is fit for surgical intervention following review by surgeon and anaesthetist
  • 4. Patient is over 18 years old at time of surgery
  • 5. Gender: male and female
  • 6. Patient must be capable of giving informed consent and agree to comply with the postoperative review program
  • 7. Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken
  • Exclusion Criteria:
  • 1. Patient is not suitable for routine primary TKA e.g. patient has ligament deficiency that requires a constrained prosthesis
  • 2. Patient has bone loss that requires augmentation
  • 3. Patient is not medically fit for surgical intervention
  • 4. Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA
  • 5. Patient has a DEXA scan with T-score \< -2.5 at any point
  • 6. Patient is immobile or has another neurological condition affecting musculoskeletal function
  • 7. Patient is less than 18 years at time of surgery
  • 8. Patient is unable or unwilling to sign the informed consent form specific to this study
  • 9. Patient is unable to attend the follow-up programme
  • 10. Previous pathological fracture

About University College, London

University College London (UCL) is a leading global research institution renowned for its commitment to advancing healthcare through innovative clinical trials. As a prominent sponsor of clinical research, UCL leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous investigations aimed at improving patient outcomes and addressing pressing medical challenges. The institution fosters collaboration among researchers, healthcare professionals, and industry partners, ensuring that its trials adhere to the highest ethical standards and regulatory guidelines. UCL's dedication to translating scientific discoveries into practical applications underscores its role as a vital contributor to the advancement of medical science and public health.

Locations

Patients applied

0 patients applied

Trial Officials

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

Study Chair

UCL Hospitals NHS Foundation Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported