Robotic Mako cementless versus cemented total knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, single-blinded controlled trial comparing Mako robotic-arm assisted cementless versus cemented total knee arthroplasty. Adult patients with symptomatic knee osteoarthritis who are fit for primary TKA will be randomized to receive either a cementless or cemented implant and followed with clinical, functional, and radiological assessments. Outcomes include functional scores, imaging for fixation and alignment, and clinical complications or revisions. The protocol excludes patients needing constrained implants, those with significant bone loss or severe osteoporosis (DEXA T-score < -2.5), and those unfit for surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• UCL Hospitals NHS Foundation Trust
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Jenni Tahmassebi, BSc MSc
• Email: jenni.tahmassebi1@nhs.net
• Phone: +442034479403

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.