Trial Outcomes & Findings for Mobile - Bearing Knee Study (NCT NCT00765362)

Last Updated: 2011-05-11

Results Overview

The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (\<70).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

419 participants

Primary outcome timeframe

2 year

Results posted on

2011-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Mobile Bearing Knee Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Overall Study STARTED	419
Overall Study COMPLETED	282
Overall Study NOT COMPLETED	137

Reasons for withdrawal

Reasons for withdrawal
Measure	Mobile Bearing Knee Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Overall Study Death	9
Overall Study Adverse Event	2
Overall Study Protocol Violation	18
Overall Study Withdrawal by Subject	13
Overall Study Lost to Follow-up	95

Baseline Characteristics

Mobile - Bearing Knee Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mobile Bearing Knee n=419 Participants Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	181 Participants n=5 Participants
Age, Categorical >=65 years	238 Participants n=5 Participants
Age Continuous	66.8 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	229 Participants n=5 Participants
Sex: Female, Male Male	190 Participants n=5 Participants
Region of Enrollment United States	419 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 year

Population: Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.

Outcome measures

Outcome measures
Measure	Mobile Bearing Knee n=173 Participants Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Knee Society Score Evaluation	93.1 Average Knee Rating Score Standard Deviation 9.9

PRIMARY outcome

Timeframe: 2 year

Population: Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.

The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of \> or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome.

Outcome measures

Outcome measures
Measure	Mobile Bearing Knee n=173 Participants Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Knee Society Function Score	89.0 Average Knee Function Score Standard Deviation 15.6

PRIMARY outcome

Timeframe: 2 year

Population: Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.

The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success.

Outcome measures

Outcome measures
Measure	Mobile Bearing Knee n=173 Participants Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Knee Society Scores Used as Success/Failure Criteria. Knee Society Score Success	91 Percentage of Participants with Success
Knee Society Scores Used as Success/Failure Criteria. Knee Function Score Success	84 Percentage of Participants with Success

Adverse Events

Mobile Bearing Knee

Serious events: 0 serious events

Other events: 281 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mobile Bearing Knee n=419 participants at risk Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
Musculoskeletal and connective tissue disorders Arthrofibrosis	2.9% 12/419 • Number of events 13 • Adverse events were collected from the date of surgery through the 2 year visit.
Immune system disorders Cancer	2.4% 10/419 • Number of events 10 • Adverse events were collected from the date of surgery through the 2 year visit.
Musculoskeletal and connective tissue disorders Degenerative Arthritis	1.9% 8/419 • Number of events 9 • Adverse events were collected from the date of surgery through the 2 year visit.
Injury, poisoning and procedural complications Knee device clicking	2.1% 9/419 • Number of events 9 • Adverse events were collected from the date of surgery through the 2 year visit.
Blood and lymphatic system disorders Edema	3.1% 13/419 • Number of events 13 • Adverse events were collected from the date of surgery through the 2 year visit.
Musculoskeletal and connective tissue disorders Fracture	1.9% 8/419 • Number of events 8 • Adverse events were collected from the date of surgery through the 2 year visit.
Cardiac disorders Heart Complications	2.4% 10/419 • Number of events 10 • Adverse events were collected from the date of surgery through the 2 year visit.
Infections and infestations Infections	3.8% 16/419 • Number of events 16 • Adverse events were collected from the date of surgery through the 2 year visit.
Nervous system disorders Neurological disorder and numbness	2.6% 11/419 • Number of events 11 • Adverse events were collected from the date of surgery through the 2 year visit.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	48.4% 203/419 • Number of events 328 • Adverse events were collected from the date of surgery through the 2 year visit.
Vascular disorders Swelling	4.5% 19/419 • Number of events 20 • Adverse events were collected from the date of surgery through the 2 year visit.

Additional Information

Manager of Clinical Affairs

DJO Surgical

Phone: 512-832-9500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60