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Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty
NA trial testing Functionally Aligned Total Knee Arthroplasty in Osteoarthritis in 100 participants. Completed in 14 November 2024.
| Lead sponsor | Perth Hip and Knee |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 30 April 2021 |
| Primary completion | 8 October 2024 |
| Estimated completion | 14 November 2024 |
| Sites | 2 locations across Australia |
Perth Hip and Knee
Adults 45 to 75, any sex, with Osteoarthritis or Osteo Arthritis Knee. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Difference in relative change in Forgotten Joint Score (2 years post-operatively compared to preoperatively) between FA and MA patients. Scale 0-100 with higher scores being a better outcome
| Group | Value | 95% CI |
|---|---|---|
| Functionally Aligned Total Knee Arthroplasty | 50.1 | ± 28.3 |
| Mechanical Axis Aligned Total Knee Arthroplasty | 46.4 | ± 32.4 |
Difference in relative change in Oxford Knee Score (2 years post-operatively compared to preoperatively) between FA and MA patients. Scale 0-48 with higher scores being a better outcome.
| Group | Value | 95% CI |
|---|---|---|
| Functionally Aligned Total Knee Arthroplasty | 17.0 | ± 7.5 |
| Mechanical Axis Aligned Total Knee Arthroplasty | 17.2 | ± 8.6 |
Difference in relative change in range of motion via goniometry (2 years post-operatively compared to preoperatively) between FA and MA patients.
| Group | Value | 95% CI |
|---|---|---|
| Functionally Aligned Total Knee Arthroplasty | 2.8 | ± 9.9 |
| Mechanical Axis Aligned Total Knee Arthroplasty | 2.8 | ± 9.3 |
Time frame: Adverse events were monitored for each participant from the time of enrolment (baseline) through to their final study visit (2 years post-operative).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Functionally Aligned Total… | Mechanical Axis Aligned To… |
|---|---|---|---|
| MUA | Injury, poisoning and procedural complications | — | — |
| Paroxsymal SVT post operative | Cardiac disorders | — | — |
Most-reported serious reactions: MUA, Paroxsymal SVT post operative.
Data from ClinicalTrials.gov NCT04748510 adverse events section.
The objective of this study is to compare clinical and radiological outcomes in robotic-arm assisted TKA using mechanical alignment (MA TKA) versus robotic-arm assisted TKA with functional alignment (FA TKA). These outcomes will be used to determine if patient recovery is better with functionally aligned Mako robotic-assisted total knee arthroplasty (FA TKA) or mechanically aligned Mako robotic-assisted total knee arthroplasty (MA TKA).
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04748510.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing