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

NCT04419311 | Completed Results FDA Device

• 1 other identifier: 1585/2017
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee; Knee Arthritis

Keywords

Ultra-congruent insert; Posterior cruciate ligament-stabilized insert; Isokinetic test; Strength; Total knee arthroplasty

Outcome Measures

Primary Outcomes (8)

• Baseline Assessment of Peak Knee Extensor Torque Preoperatively

  Peak extensor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).

  Preoperative

• Baseline Assessment of Peak Knee Flexor Torque Preoperatively

  Peak flexor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).

  Preoperative

• Assessment of Peak Knee Extensor Torque at 3 Months Postoperatively

  Peak extensor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).

  3 months postoperative

• Assessment of Peak Knee Flexor Torque at 3 Months Postoperatively

  Peak flexor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).

  3 months postoperative

• Assessment of Peak Knee Extensor Torque at 6 Months Postoperatively

  Peak extensor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).

  6 months postoperative

• Assessment of Peak Knee Flexor Torque at 6 Months Postoperatively

  Peak flexor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).

  6 months postoperative

• Assessment of Peak Knee Extensor Torque at 12 Months Postoperatively

  Peak extensor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).

  12 months postoperative

• Assessment of Peak Knee Flexor Torque at 12 Months Postoperatively

  Peak flexor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).

  12 months postoperative

Secondary Outcomes (8)

• Baseline Knee Society Clinical Score Evaluation

  Preoperative

• Knee Society Clinical Score Evaluation at 3 Months Postoperatively

  3 months postoperative

• Knee Society Clinical Score Evaluation at 6 Months Postoperatively

  6 months postoperative

• Knee Society Clinical Score Evaluation at 12 Months Postoperatively

  12 months postoperative

• Baseline Knee Society Functional Score Evaluation

  Preoperative

Study Arms (2)

Ultra-congruent insert group

EXPERIMENTAL

Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.

Device: Vanguard® Knee System

Posterior cruciate ligament-stabilized insert

EXPERIMENTAL

Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.

Device: Vanguard® Knee System

Interventions

Vanguard® Knee System DEVICE

Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.

Posterior cruciate ligament-stabilized insert; Ultra-congruent insert group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aksaray University Training and Research Hospital: lead

Study Sites (1)

Aksaray University Training and Research Hospital

Aksaray, 68200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Erdem Aras Sezgin
• Organization: Aksaray University Training and Research Hospital

sezginmd@hotmail.com

+905057777697

Study Officials

• Deniz Çankaya, MD

  Aksaray University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients and physiatrists performing isokinetic measurements were blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: Patients were randomized in a 1:1 ratio via computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle, WA, USA) to be allocated in the UC insert or PS insert group before the TKA operation (Figure 1). Unblinded senior resident implemented the randomization. Patients and physiatrists performing isokinetic measurements were blinded to group allocation.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 5, 2020
• Study Start: January 19, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: March 16, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Locations

TU (1)