N/A
Completed N=100
A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement
Arthroplasties · Knee Replacement
Source: ClinicalTrials.gov NCT02527148 ↗
Enrolled (actual)
100
Serious AEs
77.8%
Results posted
Jan 2016
Primary outcomePrimary: Oxford Knee Score — 20.3; 21.1; 32.5; 32.8 units on a scale — p=<0.0001
Summary
This is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. In this study ShapeMatch® cutting guides will be compared to the conventional approach.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxford Knee Score |
20.3; 21.1; 32.5; 32.8; 41.0; 38.2 | <0.0001 sig |
| SECONDARY Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time) |
82.6; 92.2 | 0.10 |
| SECONDARY Cost Effectiveness: Wound Length |
223; 233 | 0.05 |
| SECONDARY Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure |
— | — |
| SECONDARY Cost Effectiveness: Length of Stay in Hospital |
5.1; 4.2 | 0.07 |
| SECONDARY Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L |
0.507; 0.484; 0.895; 0.852 | 0.55 |
| SECONDARY Knee Pain |
4.36; 4.20; 5.78; 6.01; 1.95; 1.79 | 0.7240 |
| SECONDARY The Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
50.05; 50.36; 74.74; 73.06; 87.89; 81.79 | 0.911 |
| SECONDARY Health-related Quality of Life (EQ-5D-3L) |
0.51; 0.48; 71.43; 75.66; 0.67; 0.68 | 0.452 |
| SECONDARY The Forgotten Joint Score (FJS-12) |
58.12; 57.21; 60.47; 59.96; 62.47; 62.01 | 0.523 |
| SECONDARY The International Knee Society Score (IKSS) |
40.20; 37.33; 54.06; 55.50; 118.07; 116.17 | 0.3768 |
| SECONDARY Perth CT Protocol |
-0.4; -0.7; 2.0; 0.6; -2.8; -0.7 | 0.6 |
Eligibility Criteria
Inclusion Criteria
- The patient is a male or non-pregnant female between the ages of 40-80 years.
- The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
- Patient is deemed appropriate for a cruciate retaining knee replacement.
- The patient has a primary diagnosis of osteoarthritis (OA).
- The patient has intact collateral ligaments.
- The patient is able to undergo MRI scanning of the affected limb.
- The patient has signed the study specific, ethics-approved, Informed Consent document.
- The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Exclusion Criteria
- The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
- Patient has had a previous osteotomy around the knee.
- The patient is morbidly obese (BMI ≥ 40).
- The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
- The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
- The patient has a fixed flexion deformity ≥ 15°.
- The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
- Patient has a cognitive impairment, an intellectual disability or a mental illness.
- The patient is pregnant.
- The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
- The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).
Data sourced from ClinicalTrials.gov (NCT02527148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.