Trial Outcomes & Findings for Does Implant Design Improve Postoperative Flexion? (NCT NCT00380861)

NCT ID: NCT00380861

Last Updated: 2023-07-24

Results Overview

The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 93 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2023-07-24

Participant Flow

There were eight clinical investigators participating in the investigation. Subjects who were to receive simultaneous bilateral knee replacement were recruited for this study, where one knee was to receive the PFC Sigma Rotating Platform high flexion (RP-F) device and the other knee was to receive the PFC Sigma Rotating Platform (RP) device. 93 Subjects were enrolled in the study.

The randomization was a two stage scheme in order to minimize bias that could potentially be introduced due to differences in preoperative range of motion (ROM) between a subject's right and left legs.

Unit of analysis: knees

Participant milestones

Measure	PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.	PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
Overall Study STARTED	93 93	91 91
Overall Study COMPLETED	75 75	74 74
Overall Study NOT COMPLETED	18 18	17 17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subjects have a Sigma RP in one knee and a Sigma RP-F in their other knee

Baseline characteristics by cohort

Measure	PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement n=93 knees Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.	PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement n=91 knees Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.	Total n=184 knees Total of all reporting groups
Age, Continuous	61.4 years STANDARD_DEVIATION 5.6 • n=5 Participants • Subjects have a Sigma RP in one knee and a Sigma RP-F in their other knee	61.4 years STANDARD_DEVIATION 5.7 • n=7 Participants • Subjects have a Sigma RP in one knee and a Sigma RP-F in their other knee	61.4 years STANDARD_DEVIATION 5.8 • n=5 Participants • Subjects have a Sigma RP in one knee and a Sigma RP-F in their other knee
Sex: Female, Male Female	61 knees n=93 knees • there were 61 females and 32 males in the study. Each participant had a Sigma RP in one knee and a Sigma RP-F in the other	60 knees n=91 knees • there were 61 females and 32 males in the study. Each participant had a Sigma RP in one knee and a Sigma RP-F in the other	121 knees n=184 knees • there were 61 females and 32 males in the study. Each participant had a Sigma RP in one knee and a Sigma RP-F in the other
Sex: Female, Male Male	32 knees n=93 knees • there were 61 females and 32 males in the study. Each participant had a Sigma RP in one knee and a Sigma RP-F in the other	31 knees n=91 knees • there were 61 females and 32 males in the study. Each participant had a Sigma RP in one knee and a Sigma RP-F in the other	63 knees n=184 knees • there were 61 females and 32 males in the study. Each participant had a Sigma RP in one knee and a Sigma RP-F in the other
Region of Enrollment United States · United States	93 knees n=93 knees	91 knees n=91 knees	184 knees n=184 knees

PRIMARY outcome

Timeframe: 6 months

The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.

Outcome measures

Measure	Passive Flexion for Standard Knee Device at Pre-op n=93 Knees Single leg passive flexion for Standard Knee Device at pre-op	Passive Flexion for Standard Knee Device at 6-months n=91 Knees Single leg passive flexion for Standard Knee Device at 6-months	Passive Flexion for Standard Knee Device at 12-months Single leg passive flexion for Standard Knee Device at 12-months	Passive Flexion for High Flexion Knee Device at Pre-op Single leg passive flexion High Flexion Knee Device at pre-op	Passive Flexion for High Flexion Knee Device at 6-months Single leg passive flexion for High Flexion Knee Device at 6-months	Passive Flexion for High Flexion Knee Device at 12-months Single leg passive flexion for High Flexion Knee Device at 12-months
Knee Society Passive Flexion at 6 Months	124.2 Degrees of passive flexion Standard Deviation 11.2	124.0 Degrees of passive flexion Standard Deviation 10.6	—	—	—	—

SECONDARY outcome

Timeframe: Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months

The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.

Outcome measures

Measure	Passive Flexion for Standard Knee Device at Pre-op n=19 Knees Single leg passive flexion for Standard Knee Device at pre-op	Passive Flexion for Standard Knee Device at 6-months n=16 Knees Single leg passive flexion for Standard Knee Device at 6-months	Passive Flexion for Standard Knee Device at 12-months n=18 Knees Single leg passive flexion for Standard Knee Device at 12-months	Passive Flexion for High Flexion Knee Device at Pre-op n=20 Knees Single leg passive flexion High Flexion Knee Device at pre-op	Passive Flexion for High Flexion Knee Device at 6-months n=17 Knees Single leg passive flexion for High Flexion Knee Device at 6-months	Passive Flexion for High Flexion Knee Device at 12-months n=18 Knees Single leg passive flexion for High Flexion Knee Device at 12-months
Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee	111.6 Degrees of passive flexion Standard Deviation 6.0	118.9 Degrees of passive flexion Standard Deviation 13.9	120.2 Degrees of passive flexion Standard Deviation 11.3	111.4 Degrees of passive flexion Standard Deviation 5.8	120.9 Degrees of passive flexion Standard Deviation 12.7	124.7 Degrees of passive flexion Standard Deviation 9.8

SECONDARY outcome

Timeframe: Collected at pre-op

Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes.

Outcome measures

Measure	Passive Flexion for Standard Knee Device at Pre-op n=93 Participants Single leg passive flexion for Standard Knee Device at pre-op	Passive Flexion for Standard Knee Device at 6-months n=93 Participants Single leg passive flexion for Standard Knee Device at 6-months	Passive Flexion for Standard Knee Device at 12-months n=93 Participants Single leg passive flexion for Standard Knee Device at 12-months	Passive Flexion for High Flexion Knee Device at Pre-op Single leg passive flexion High Flexion Knee Device at pre-op	Passive Flexion for High Flexion Knee Device at 6-months Single leg passive flexion for High Flexion Knee Device at 6-months	Passive Flexion for High Flexion Knee Device at 12-months Single leg passive flexion for High Flexion Knee Device at 12-months
Patient Specific Anthropometrics	50.2 Centimeters Standard Deviation 6.3	24.8 Centimeters Standard Deviation 2.7	3.23 Centimeters Standard Deviation 1.46	—	—	—

SECONDARY outcome

Timeframe: Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval

AKS Score post-op at 12-months is reported for the final visit AKS score is a 0 -100-point scale with 100 being best knee condition.

Outcome measures

Measure	Passive Flexion for Standard Knee Device at Pre-op n=80 Knees Single leg passive flexion for Standard Knee Device at pre-op	Passive Flexion for Standard Knee Device at 6-months n=81 Knees Single leg passive flexion for Standard Knee Device at 6-months	Passive Flexion for Standard Knee Device at 12-months Single leg passive flexion for Standard Knee Device at 12-months	Passive Flexion for High Flexion Knee Device at Pre-op Single leg passive flexion High Flexion Knee Device at pre-op	Passive Flexion for High Flexion Knee Device at 6-months Single leg passive flexion for High Flexion Knee Device at 6-months	Passive Flexion for High Flexion Knee Device at 12-months Single leg passive flexion for High Flexion Knee Device at 12-months
American Knee Society (AKS) Score	85.6 Units on a scale Standard Deviation 11.5	87.0 Units on a scale Standard Deviation 10.7	—	—	—	—

SECONDARY outcome

Timeframe: Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up

KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain activity of daily living, sports/recreation and quality of life. Further, the sub-score for pain is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

Outcome measures

Measure	Passive Flexion for Standard Knee Device at Pre-op n=86 Knees Single leg passive flexion for Standard Knee Device at pre-op	Passive Flexion for Standard Knee Device at 6-months n=67 Knees Single leg passive flexion for Standard Knee Device at 6-months	Passive Flexion for Standard Knee Device at 12-months n=79 Knees Single leg passive flexion for Standard Knee Device at 12-months	Passive Flexion for High Flexion Knee Device at Pre-op n=88 Knees Single leg passive flexion High Flexion Knee Device at pre-op	Passive Flexion for High Flexion Knee Device at 6-months n=68 Knees Single leg passive flexion for High Flexion Knee Device at 6-months	Passive Flexion for High Flexion Knee Device at 12-months n=80 Knees Single leg passive flexion for High Flexion Knee Device at 12-months
KOOS Pain Sub-score	45.7 Units on a scale Standard Deviation 19.2	84.0 Units on a scale Standard Deviation 14.8	89.5 Units on a scale Standard Deviation 14.0	45.3 Units on a scale Standard Deviation 18.2	83.1 Units on a scale Standard Deviation 14.9	90.0 Units on a scale Standard Deviation 11.8

SECONDARY outcome

Timeframe: Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months

KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain, activity of daily living, sports/recreation and quality of life. The score is a percentage score from 0 to 100 with 0 representing extreme problems and 100 representing no problems.

Outcome measures

Measure	Passive Flexion for Standard Knee Device at Pre-op n=79 Knees Single leg passive flexion for Standard Knee Device at pre-op	Passive Flexion for Standard Knee Device at 6-months n=69 Knees Single leg passive flexion for Standard Knee Device at 6-months	Passive Flexion for Standard Knee Device at 12-months n=75 Knees Single leg passive flexion for Standard Knee Device at 12-months	Passive Flexion for High Flexion Knee Device at Pre-op n=83 Knees Single leg passive flexion High Flexion Knee Device at pre-op	Passive Flexion for High Flexion Knee Device at 6-months n=69 Knees Single leg passive flexion for High Flexion Knee Device at 6-months	Passive Flexion for High Flexion Knee Device at 12-months n=75 Knees Single leg passive flexion for High Flexion Knee Device at 12-months
Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs	49.0 Points on a scale Standard Deviation 20.2	85.4 Points on a scale Standard Deviation 14.0	90.4 Points on a scale Standard Deviation 11.8	47.9 Points on a scale Standard Deviation 19.2	85.6 Points on a scale Standard Deviation 12.7	90.1 Points on a scale Standard Deviation 11.3

SECONDARY outcome

Timeframe: Collected at Pre-operative, 6 weeks and 6 and 12 months

Population: Patellar crepitus is measured by touch with the clinician placing a hand over the knee cap and moving the lower leg from flexion to extension. It is classified as coarse, fine or no crepitus.

Patellar Crepitus (grinding in the knee) analyzed and reported for pre-op, 6-months and 12-months and classified as No Crepitus, FINE or COARSE.

Outcome measures

Measure	Passive Flexion for Standard Knee Device at Pre-op n=91 Knees Single leg passive flexion for Standard Knee Device at pre-op	Passive Flexion for Standard Knee Device at 6-months n=92 Knees Single leg passive flexion for Standard Knee Device at 6-months	Passive Flexion for Standard Knee Device at 12-months n=74 Knees Single leg passive flexion for Standard Knee Device at 12-months	Passive Flexion for High Flexion Knee Device at Pre-op n=75 Knees Single leg passive flexion High Flexion Knee Device at pre-op	Passive Flexion for High Flexion Knee Device at 6-months n=78 Knees Single leg passive flexion for High Flexion Knee Device at 6-months	Passive Flexion for High Flexion Knee Device at 12-months n=78 Knees Single leg passive flexion for High Flexion Knee Device at 12-months
Patellar Crepitus Defined as No Crepitus, FINE or COARSE FINE Crepitus	31 Knees	37 Knees	21 Knees	29 Knees	22 Knees	22 Knees
Patellar Crepitus Defined as No Crepitus, FINE or COARSE COARSE Crepitus	45 Knees	42 Knees	9 Knees	5 Knees	4 Knees	4 Knees
Patellar Crepitus Defined as No Crepitus, FINE or COARSE NO Crepitus	15 Knees	13 Knees	44 Knees	41 Knees	52 Knees	52 Knees

SECONDARY outcome

Timeframe: Collected pre-and post-op, reported at 12-months

Secondary objective to compare the pre-op goals and post-op satisfaction through the interpretation of data collected with the use of Palm technology for bilateral knee patients

Outcome measures

Measure	Passive Flexion for Standard Knee Device at Pre-op n=91 Participants Single leg passive flexion for Standard Knee Device at pre-op	Passive Flexion for Standard Knee Device at 6-months Single leg passive flexion for Standard Knee Device at 6-months	Passive Flexion for Standard Knee Device at 12-months Single leg passive flexion for Standard Knee Device at 12-months	Passive Flexion for High Flexion Knee Device at Pre-op Single leg passive flexion High Flexion Knee Device at pre-op	Passive Flexion for High Flexion Knee Device at 6-months Single leg passive flexion for High Flexion Knee Device at 6-months	Passive Flexion for High Flexion Knee Device at 12-months Single leg passive flexion for High Flexion Knee Device at 12-months
Subject Satisfaction	84 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-op, 6- and 12-months

Weight-bearing single leg active flexion (SLAF). A medically trained professional conducts this test using a goniometer, which is an angle-measuring device. Of note, pre-op patients have a lower number because they were unable or unwilling to participate in SLAF due to pain.

Outcome measures

Measure	Passive Flexion for Standard Knee Device at Pre-op n=27 knees Single leg passive flexion for Standard Knee Device at pre-op	Passive Flexion for Standard Knee Device at 6-months n=70 knees Single leg passive flexion for Standard Knee Device at 6-months	Passive Flexion for Standard Knee Device at 12-months n=73 knees Single leg passive flexion for Standard Knee Device at 12-months	Passive Flexion for High Flexion Knee Device at Pre-op n=31 knees Single leg passive flexion High Flexion Knee Device at pre-op	Passive Flexion for High Flexion Knee Device at 6-months n=72 knees Single leg passive flexion for High Flexion Knee Device at 6-months	Passive Flexion for High Flexion Knee Device at 12-months n=74 knees Single leg passive flexion for High Flexion Knee Device at 12-months
Single Leg Active Flexion (SLAF)	124.6 Degrees of flexion Standard Deviation 11.1	126.0 Degrees of flexion Standard Deviation 11.0	126.6 Degrees of flexion Standard Deviation 10.6	120.9 Degrees of flexion Standard Deviation 13.3	125.2 Degrees of flexion Standard Deviation 10.8	127.5 Degrees of flexion Standard Deviation 11.1

Adverse Events

PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement n=93 participants at risk Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.	PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement n=91 participants at risk Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
Infections and infestations Infection	1.1% 1/93 • Number of events 2	1.1% 1/91 • Number of events 1
Injury, poisoning and procedural complications Loosening	1.1% 1/93 • Number of events 1	1.1% 1/91 • Number of events 1
Injury, poisoning and procedural complications Polyethylene Failure	1.1% 1/93 • Number of events 1	0.00% 0/91

Other adverse events

Measure	PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement n=93 participants at risk Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.	PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement n=91 participants at risk Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
Musculoskeletal and connective tissue disorders Musculoskeletal	5.4% 5/93 • Number of events 6	4.4% 4/91 • Number of events 4
Respiratory, thoracic and mediastinal disorders Respiratory	8.6% 8/93 • Number of events 10	8.8% 8/91 • Number of events 10

Additional Information

Tammy O'Dell

DePuy Orthopaedics

Phone: 574-372-7104

Email: TOdell2@its.jnj.com

Results disclosure agreements

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

Restriction type: LTE60