Compares treatment options for Total Knee Replacement
Official title Mako Cementless TKA vs Mako Cemented TKA
ClinicalTrials.gov ID: NCT06929871
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.