Robotic Mako cementless versus cemented total knee replacement
A Prospective Randomised Controlled Trial Comparing Cementless Mako Robotic-arm Assisted Total Knee Arthroplasty Versus Cemented Mako Robotic-arm Assisted Total Knee Arthroplasty.
This study will test whether robotic Mako cementless or cemented knee replacements work better for adults having a primary total knee replacement for osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06929871 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults over 18 with symptomatic knee osteoarthritis who are judged suitable for primary total knee arthroplasty, able to consent, and able to attend follow-up visits are ideal candidates.
Not a fit: Patients with ligament deficiency requiring constrained prostheses, significant bone loss or augmentation, prior ipsilateral revision surgery, severe osteoporosis (T-score < -2.5), or who are not medically fit for surgery are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, this could improve implant fixation and function and reduce revision risk for people receiving knee replacements.
How similar studies have performed: Registry data and recent reports on modern cementless designs and robotic-assisted TKA show promising short- to mid-term outcomes, but randomized comparisons with long-term follow-up remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- UCL Hospitals NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jenni Tahmassebi, BSc MSc
- Email: jenni.tahmassebi1@nhs.net
- Phone: +442034479403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.