Trial Outcomes & Findings for Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior Stabilized Total Knee Arthroplasties (NCT NCT04419311)

NCT ID: NCT04419311

Last Updated: 2021-03-16

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: Preoperative
• Results posted on: 2021-03-16

Participant Flow

Participant milestones

Measure	Ultra-congruent Insert Group Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Overall Study STARTED	33	33
Overall Study COMPLETED	32	33
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Ultra-congruent Insert Group Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ultra-congruent Insert Group n=33 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.	Total n=66 Participants Total of all reporting groups
Age, Continuous	69.18 years STANDARD_DEVIATION 8.55 • n=33 Participants	67.67 years STANDARD_DEVIATION 8.12 • n=33 Participants	68.42 years STANDARD_DEVIATION 8.31 • n=66 Participants
Sex: Female, Male Female	29 Participants n=33 Participants	26 Participants n=33 Participants	55 Participants n=66 Participants
Sex: Female, Male Male	4 Participants n=33 Participants	7 Participants n=33 Participants	11 Participants n=66 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Turkey	33 participants n=33 Participants	33 participants n=33 Participants	66 participants n=66 Participants

PRIMARY outcome

Timeframe: Preoperative

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).

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Baseline Assessment of Peak Knee Extensor Torque Preoperatively	55.56 Newton meters Standard Deviation 8.65	58.33 Newton meters Standard Deviation 8.96

PRIMARY outcome

Timeframe: Preoperative

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).

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Baseline Assessment of Peak Knee Flexor Torque Preoperatively	37.84 Newton meters Standard Deviation 9.56	40.3 Newton meters Standard Deviation 7.79

PRIMARY outcome

Timeframe: 3 months postoperative

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).

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Assessment of Peak Knee Extensor Torque at 3 Months Postoperatively	44.38 Newton meters Standard Deviation 7.37	45.85 Newton meters Standard Deviation 7.46

PRIMARY outcome

Timeframe: 3 months postoperative

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).

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Assessment of Peak Knee Flexor Torque at 3 Months Postoperatively	31.91 Newton meters Standard Deviation 10.11	29.39 Newton meters Standard Deviation 7.16

PRIMARY outcome

Timeframe: 6 months postoperative

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).

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Assessment of Peak Knee Extensor Torque at 6 Months Postoperatively	53.53 Newton meters Standard Deviation 7.95	52.64 Newton meters Standard Deviation 6.83

PRIMARY outcome

Timeframe: 6 months postoperative

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).

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Assessment of Peak Knee Flexor Torque at 6 Months Postoperatively	36.19 Newton meters Standard Deviation 9.86	35.27 Newton meters Standard Deviation 7.35

PRIMARY outcome

Timeframe: 12 months postoperative

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).

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Assessment of Peak Knee Extensor Torque at 12 Months Postoperatively	59.34 Newton meters Standard Deviation 8.97	61.52 Newton meters Standard Deviation 9.88

PRIMARY outcome

Timeframe: 12 months postoperative

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).

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Assessment of Peak Knee Flexor Torque at 12 Months Postoperatively	39.94 Newton meters Standard Deviation 9.96	41.18 Newton meters Standard Deviation 7.63

SECONDARY outcome

Timeframe: Preoperative

The Knee Society Score were applied preoperatively.

The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Baseline Knee Society Clinical Score Evaluation	47.69 score on a scale Standard Deviation 12.6	49.15 score on a scale Standard Deviation 11.68

SECONDARY outcome

Timeframe: 3 months postoperative

The Knee Society Clinical Score were applied at postoperative 3 months.

The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Knee Society Clinical Score Evaluation at 3 Months Postoperatively	78.81 score on a scale Standard Deviation 11.73	79.48 score on a scale Standard Deviation 10.80

SECONDARY outcome

Timeframe: 6 months postoperative

The Knee Society Clinical Score were applied at postoperative 6 months.

The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Knee Society Clinical Score Evaluation at 6 Months Postoperatively	86.81 score on a scale Standard Deviation 5.64	88.39 score on a scale Standard Deviation 6.29

SECONDARY outcome

Timeframe: 12 months postoperative

The Knee Society Clinical Score were applied at postoperative 12 months.

The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Knee Society Clinical Score Evaluation at 12 Months Postoperatively	90.69 score on a scale Standard Deviation 4.41	92.24 score on a scale Standard Deviation 4.44

SECONDARY outcome

Timeframe: Preoperative

The Knee Society Functional Score were applied preoperatively.

The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Baseline Knee Society Functional Score Evaluation	49.53 units on a scale Standard Deviation 14.11	51.27 units on a scale Standard Deviation 11.60

SECONDARY outcome

Timeframe: 3 months postoperative

The Knee Society Functional Score were applied at postoperative 3 months.

The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Knee Society Functional Score Evaluation at 3 Months Postoperatively	64.47 units on a scale Standard Deviation 14.19	65.73 units on a scale Standard Deviation 11.90

SECONDARY outcome

Timeframe: 6 months postoperative

The Knee Society Functional Score were applied at postoperative 6 months.

The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Knee Society Functional Score Evaluation at 6 Months Postoperatively	70.22 units on a scale Standard Deviation 12.98	72.21 units on a scale Standard Deviation 11.73

SECONDARY outcome

Timeframe: 12 months postoperative

The Knee Society Functional Score were applied at postoperative 12 months.

The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.

Outcome measures

Measure	Ultra-congruent Insert Group n=32 Participants Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 Participants Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Knee Society Functional Score Evaluation at 12 Months Postoperatively	81.47 units on a scale Standard Deviation 10.45	82.79 units on a scale Standard Deviation 10.06

Adverse Events

Ultra-congruent Insert Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Posterior Cruciate Ligament-stabilized Insert

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ultra-congruent Insert Group n=32 participants at risk Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.	Posterior Cruciate Ligament-stabilized Insert n=33 participants at risk Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
Vascular disorders Deep vein thrombosis	3.1% 1/32 • Number of events 1 • 1 year Definition of adverse event does not differ from the clinicaltrials.gov definitions.	3.0% 1/33 • Number of events 1 • 1 year Definition of adverse event does not differ from the clinicaltrials.gov definitions.
Infections and infestations Superficial infection	0.00% 0/32 • 1 year Definition of adverse event does not differ from the clinicaltrials.gov definitions.	3.0% 1/33 • Number of events 1 • 1 year Definition of adverse event does not differ from the clinicaltrials.gov definitions.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erdem Aras Sezgin

Aksaray University Training and Research Hospital

Phone: +905057777697

Email: sezginmd@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place