Sigma CR150 Versus Sigma CR Knee RCT
Source: ClinicalTrials.gov NCT01418378 ↗No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Knees Who Survived at 2 Years Post-operative |
100; 100 | — |
| SECONDARY Change From Baseline in Goniometer Measured Maximum Passive Flexion at 2 Years |
-3.37; -0.67 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Pain Subscore - 1 Year |
46.59; 48.54 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Pain Subscore - 2 Years |
51.50; 55.38 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Symptoms Subscore - 1 Years |
44.00; 39.99 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Symptom Subscore - 2 Years |
38.59; 40.65 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 1 Years |
44.00; 39.99 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 2 Years |
38.59; 40.65 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome - Sport and Recreation Subscore - 1 Years |
46.99; 46.42 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Sport and Recreation Subscore - 2 Years |
61.29; 60.40 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 1 Years |
50.75; 49.59 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 2 Years |
60.33; 59.92 | — |
| SECONDARY Change From Baseline in Goniometer Measured Maximum Passive Flexion at 1 Year. |
-1.03; -0.23 | — |
| SECONDARY Change From Baseline in Goniometer Measured Maximum Passive Extension at 1 Year |
-2.34; -3.15 | — |
| SECONDARY Change From Baseline in Goniometer Measured Maximum Passive Extension at 2 Years |
-2.63; -3.44 | — |
| SECONDARY Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 1 Year |
1.31; 2.92 | — |
| SECONDARY Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 2 Years. |
-0.74; 2.78 | — |
| SECONDARY Number of Participants With Flexion Contracture at 1 Year |
7; 5; 1; 0 | — |
| SECONDARY Number of Participants With Flexion Contracture at 2 Years |
4; 2; 0; 0 | — |
| SECONDARY Total Knee Society Score at 1 Year |
45.07; 52.50 | — |
| SECONDARY Total Knee Society Knee Score at 2 Years |
46.44; 54.51 | — |
| SECONDARY Anatomic Alignment Angle |
3; 0; 66; 65 | — |
| SECONDARY Alignment - Femoral Component to Anatomic Angle. |
94.37; 94.21 | — |
| SECONDARY Alignment - Femoral Component to Anatomic Angle |
93.94; 94.48 | — |
| SECONDARY Alignment - Tibial Component to Anatomic Angle |
89.69; 90.19 | — |
| SECONDARY Alignment - Femoral Component Flexion |
89.93; 89.80 | — |
| SECONDARY Alignment - Tibial Posterior Slope |
85.99; 85.15 | — |
| SECONDARY Number of Subjects With Radiolucencies - Femoral Component |
0; 2; 2; 1 | — |
| SECONDARY Number of Subjects With Radiolucencies - Tibial Component |
0; 1; 0; 1 | — |
| SECONDARY Radiographic Evaluation of Maximum Flexion |
108.51; 107.11 | — |
Eligibility Criteria
Inclusion Criteria
i)Male or female subjects, aged between 50 and 75 years inclusive.
ii)Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
iii) Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
iv) Subjects defined by the Investigator as ASA Grade I or II.
v) Subjects with a primary diagnosis of osteoarthritis.
vi) Subjects who require a primary total knee arthroplasty.
vii) Subjects who can achieve active flexion of 90 degrees.
Exclusion Criteria
i) Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
ii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
iii) Subjects who have participated in a clinical investigation with an investigational product in the last month.
iv) Subjects who are currently involved in any injury litigation claims.
v) Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.
vi) Subjects with a fixed flexion deformity of over 20 degrees.
vii) Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).
viii) Subjects who cannot flex their hip to 90 degrees.
ix) Subjects with a BMI of 35 or above.
x) Subjects defined by the Investigator as ASA Grade III-V.
xi) Subjects who are identified pre-operatively as having bone defects which require augmentation.
xii) Subjects who have previously undergone total or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, ORIF or with previous fracture in the knee joint.
xiii) Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.
xiv) Subjects who have undergone contralateral total knee arthroplasty during the previous 6 months.
xv) Subjects who in the opinion of the Investigator require patellar resurfacing.
Intra-operative exclusion criteria:
i) Subjects who have uncontained bone defects or defects bigger than 8 mm3 and/or require augmentation.
ii) Subjects who are not suitable to receive both the study and comparator devices.
iii) Subjects who require patellar resurfacing
Data sourced from ClinicalTrials.gov (NCT01418378). 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.