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| ID | Type | Description | Link |
|---|---|---|---|
| B3222022001251 | Other Identifier | Ethics Committee Research UZ/KU Leuven |
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General Aim: to explore the iKA in TKA related to clinical, biomechanical, and functional outcomes.
First specific aim: to investigate the kinematics during daily functional movements in individuals with the iKA TKA to those with aMA TKA, as well as the healthy control group.
Second specific aim: to investigate kinetics and muscle activation patterns during functional movements in individuals with the iKA aligned TKA to those with aMA TKA, as well as a healthy control group.
Third specific aim: to investigate the impact of the whole body on functional outcomes following iKA and aMA TKA, in comparison to the healthy control group, and to explore the underlying factors contributing to suboptimal outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| To examine the lower limb kinematic differences during the challenging daily functional movements, s | Experimental | To examine the lower limb kinematic differences during the challenging daily functional movements, such as the lunge, in individuals who have undergone iKA TKA, compared to those with aMA TKA and healthy controls. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iKA | Procedure | This study compared inverse kinematic alignment (iKA) TKA, which preserves native JLO, with adjusted mechanical alignment (aMA) TKA, which standardizes JLO to 90°, and a healthy control group across eight functional activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Stadiometer; height in millimeters | 2 years after TKA |
| Joint angles | Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit: Degrees | 2 years after surgery |
| Age | year | 2 years after TKA |
| Leg Length | Direct Tape Measure; Leg Length in millimeters | 2 years after TKA |
| Inter-ASIS Dist | Vernier caliper， Inter-ASIS Dist in millimeters | 2 years after TKA |
| Knee Width | Vernier caliper, Knee Width in millimeters | 2 years after TKA |
| Ankle Width | Vernier caliper, Ankle Width in millimeters | 2 years after TKA |
| Elbow Width | Vernier caliper, Elbow Width in millimeters | 2 years after TKA |
| Wrist Width | Vernier caliper, Wrist Width in millimeters |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | weight and height will be combined to report BMI in kg/m2 | 2 years after TKA |
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Inclusion Criteria:
were age under 85 years. primary robot-assisted TKA using either iKA or aMA. surgery performed two years before enrollment. independent ambulation without assistive devices; and informed consent.
Exclusion Criteria:
history of lower limb trauma or fracture. neurological disorders (e.g., stroke, Parkinson's disease, multiple sclerosis). systemic musculoskeletal diseases (e.g., rheumatoid arthritis, diabetic neuropathy).
revision arthroplasty. and cognitive impairment affecting study participation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KULeuven | Bruges | West | 8200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35513224 | Result | Winnock de Grave P, Kellens J, Luyckx T, Tampere T, Lacaze F, Claeys K. Inverse Kinematic Alignment for Total Knee Arthroplasty. Orthop Traumatol Surg Res. 2022 Sep;108(5):103305. doi: 10.1016/j.otsr.2022.103305. Epub 2022 May 2. |
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it is a 15 year study
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 27, 2025 | Jan 19, 2026 | Prot_SAP_000.pdf |
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| 2 years after TKA |
| Hand Thickness | Vernier caliper, Hand Thickness in millimeters | 2 years after TKA |
| Total Gait Cycle Duration | Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit in second | 2 years after TKA |
| Visual Analog Scale | Pain Scores | Pre-TKA, 6 weeks after TKA, 2 years after TKA |
| Oxford Knee Score (OKS) | total score ranging from 0 to 48 | Pre-TKA; 2 years after TKA |
| maximum voluntary isometric strength tests of the lower limb | Peak force measured with a hand-held dynamometer (Micro FET 2 Handheld Dynamometer, Hoggan, USA); Unit: Newtons | 2 years after TKA |
| Muscle activity patterns for eight muscles (gluteus medius, rectus femoris, vastus medialis, vastus lateralis, biceps femoris, semitendinosus, tibialis anterior and gastrocnemius medialis) | A 16-channel telemetric wireless surface electromyography (EMG) system (Waveplus®, Cometa, Rome, Italy) operating at 1000 Hz was utilized. Unit: Volt | 2 years after TKA |