N/A N=66 Randomized Double-blind Treatment

Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior Stabilized Total Knee Arthroplasties

Osteoarthritis, Knee · Knee Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT04419311 ↗

Enrolled (actual)

Serious AEs

4.6%

Results posted

Feb 2021

Primary outcome: Primary: Baseline Assessment of Peak Knee Extensor Torque Preoperatively — 55.56; 58.33 Newton meters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Vanguard® Knee System (Device)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: Aksaray University Training and Research Hospital
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline Assessment of Peak Knee Extensor Torque Preoperatively	55.56; 58.33	—
PRIMARY Baseline Assessment of Peak Knee Flexor Torque Preoperatively	37.84; 40.3	—
PRIMARY Assessment of Peak Knee Extensor Torque at 3 Months Postoperatively	44.38; 45.85	—
PRIMARY Assessment of Peak Knee Flexor Torque at 3 Months Postoperatively	31.91; 29.39	—
PRIMARY Assessment of Peak Knee Extensor Torque at 6 Months Postoperatively	53.53; 52.64	—
PRIMARY Assessment of Peak Knee Flexor Torque at 6 Months Postoperatively	36.19; 35.27	—
PRIMARY Assessment of Peak Knee Extensor Torque at 12 Months Postoperatively	59.34; 61.52	—
PRIMARY Assessment of Peak Knee Flexor Torque at 12 Months Postoperatively	39.94; 41.18	—
SECONDARY Baseline Knee Society Clinical Score Evaluation	47.69; 49.15	—
SECONDARY Knee Society Clinical Score Evaluation at 3 Months Postoperatively	78.81; 79.48	—
SECONDARY Knee Society Clinical Score Evaluation at 6 Months Postoperatively	86.81; 88.39	—
SECONDARY Knee Society Clinical Score Evaluation at 12 Months Postoperatively	90.69; 92.24	—
SECONDARY Baseline Knee Society Functional Score Evaluation	49.53; 51.27	—
SECONDARY Knee Society Functional Score Evaluation at 3 Months Postoperatively	64.47; 65.73	—
SECONDARY Knee Society Functional Score Evaluation at 6 Months Postoperatively	70.22; 72.21	—
SECONDARY Knee Society Functional Score Evaluation at 12 Months Postoperatively	81.47; 82.79	—

Summary

The choice between ultra-congruent (UC) insert or posterior cruciate ligament-stabilized (PS) insert in posterior cruciate ligament (PCL) sacrificing total knee arthroplasty (TKA) remains debatable. Despite the potential advantages of the UC insert over PS insert with its different design, there are concerns about inferior clinical outcome related to its use. Therefore, isokinetic performance was used in this study to objectively evaluate knee function after TKA and the clinical scores of the patients were also evaluated. To the best of our knowledge, no prospective randomized study has compared the isokinetic performance of the knee following the use of UC and PS inserts in TKA. The hypothesis of the present study was that compared with the PS insert, the UC insert would be associated with a lower clinical outcome and isokinetic performance following TKA. A total of 65 patients scheduled to undergo TKA on for primary knee osteoarthritis were randomly assigned to either the UC (32 patients) or the PS group (33 patients). The Knee Society Score (KSS) and isokinetic performance results of each patient were recorded preoperatively and at postoperative 3, 6 and 12 months. The physiatrist performing isokinetic tests and patients were blinded to the study.

Eligibility Criteria

Inclusion Criteria

Age between 55 and 80 years
Scheduled to undergo unilateral TKA on for primary knee osteoarthritis

Exclusion Criteria

Rheumatological joint diseases
Previous knee surgery
Neuromuscular diseases
Bilateral TKA
Insufficiency of collateral ligaments

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04419311). 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.