Clinical trial NCT04092153: Mako Functionally Aligned Total Knee Arthroplasty vs Mako Mechanically Aligned Total Knee Arthroplasty
Official title: A Prospective Randomised Control Trial Comparing Mako Robotic-arm Assisted Functionally Aligned Total Knee Arthroplasty Versus Mako Robotic-arm Assisted Mechanically Aligned Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteo Arthritis Knee
Osteoarthritis
Surgery
Keywords: total knee arthroplasty
total knee replacement
functional alignment
kinematic alignment
robotic surgery
mako robot
makoplasty
patient outcomes
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2019-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates outcomes of robotic-arm assisted mechanically aligned total knee arthroplasty \[MA TKA\] versus robotic-arm assisted functionally aligned total knee arthroplasty \[FA TKA\]. Half the study will receive MA TKA and half will receive FA TKA.

Detailed description: Total knee arthroplasty \[TKA\] is an estabilshed treatment for symptomatic end-stage knee osteoarthritis, but there is a higher disatisfaction rate when compared to total hip arthroplasty. The exact aetiology of this is not clear but recent studies have shown one possible reason to be conventional TKA with mechanical alignment \[MA\] may force the knee into an unnatural position. This may lead to altered knee anatomy and kinematics that may compromise patient satisfaction.

Total knee arthroplasty using functional alignment \[FA\] aims to restore the patient's prearthritic knee anatomy and native joint kinematics. Early clinical and functional outcome studies have reported promising outcomes in TKA with FA but results of longer term studies have not yet been published.

There are very few prospective studies exploring clinical and radiological outcomes in MA versus FA for TKA. It is possible to improve on previous studies by recording a more comprehensive range of clinical and functional outcome measures, blinding patients and observers recording outcomes of interest, and using longer follow-up times.

Robotic-arm assistance can be used to improve the accuracy of implant positioning. Clinical and functional outcomes should also be correlated to longer-term outcomes to better establish the "safe zone" for functional alignment. The findings of this study will enable an improved understanding of the clinical and functional benefits of FA compared to MA. These outcomes will improve our understanding of the optimal TKA alignment with possible improved outcomes; improved cost-effectiveness by reduced revisions and better patient satisfaction and function; and improved long-term implant survival.

100 patients will be enrolled in a 1:1 ratio between the two treatment groups. Trial patient will be allocated to either the MA TKA \['Control group'\] or to the FA TKA \['Investigation group'\]. Outcomes will be recorded at specific milestones.

Eligibility criteria: Inclusion 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 between 18-80 years of age 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 be a permanent resident in an area accessible to the study site
* Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken

Exclusion Criteria:

* 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 is immobile or has another neurological condition affecting musculoskeletal function
* Patient is less than 18 years of age or greater than 80 years of age
* Patient is already enrolled on another concurrent clinical trial
* Patient is unable or unwilling to sign the informed consent form specific to this study
* Patient is unable to attend the follow-up programme
* Patient is non-resident in local area or expected to leave the catchment area postoperatively

Primary outcomes:
measure: Western Ontario and Mcmaster Universities Arthritis Index (WOMAC)
timeFrame: 2 years post-intervention
Secondary outcomes:
measure: Lower limb alignment
timeFrame: pre op and 6 weeks post op
measure: Operating time
timeFrame: interoperative
measure: Time to discharge
timeFrame: Documented when participant leaves hospital, an average of 72 -96 hours
measure: Forgotten Joint Score (FJS)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Oxford Knee Score (OKS)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Short form health survey of 12 items (SF-12),
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: University of California at Los Angeles knee (UCLA)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Use of mobility aids
timeFrame: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
measure: Mobilisation distance
timeFrame: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
measure: Range of movement
timeFrame: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years
measure: radiosteriometric analysis (RSA)
timeFrame: postoperatively at 2 weeks, 6 weeks, 6 months, 1 year, and 2 years
measure: Gait analysis
timeFrame: performed postoperatively at 6 months and 1 year postoperatively
measure: Complications
timeFrame: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust
Study officials:
affiliation: UCLH
name: Fares S Haddad
role: STUDY_CHAIR
References:
citation: Kayani B, Konan S, Tahmassebi J, Oussedik S, Moriarty PD, Haddad FS. A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty. Trials. 2020 Feb 18;21(1):194. doi: 10.1186/s13063-020-4123-8.