Trial Outcomes & Findings for The 3DKnee™ System: A Post-Market Study (NCT NCT00764673)

Last Updated: 2011-03-02

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

PHASE4

Target enrollment

71 participants

Primary outcome timeframe

2 year

Results posted on

2011-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Primary 3DKnee Implant Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Overall Study STARTED	71
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Primary 3DKnee Implant Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Overall Study Death	1
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	6
Overall Study Revision of Device	2

Baseline Characteristics

The 3DKnee™ System: A Post-Market Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary 3DKnee Implant n=71 Participants Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	46 Participants n=5 Participants
Age Continuous	69 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants
Operated Knee Right knee	36 participants n=5 Participants
Operated Knee Left knee	35 participants n=5 Participants
Primary Diagnosis Osteoarthritis	69 participants n=5 Participants
Primary Diagnosis Varus deformity	1 participants n=5 Participants
Primary Diagnosis Post-traumatic arthritis	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 year

Population: The number of subjects who completed their 2 year visit.

Outcome measures

Outcome measures
Measure	Primary 3DKnee Implant n=59 Participants Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Knee Society Score Evaluation	82.9 Average Knee Rating Score Standard Deviation 25.7

PRIMARY outcome

Timeframe: 2-year

Population: The number of subjects who completed their 2 year visit and had available data to collect for this evaluation.

The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, 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.

Outcome measures

Outcome measures
Measure	Primary 3DKnee Implant n=54 Participants Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Knee Society Function Score	76.6 Average Knee Function Score Standard Deviation 20.0

PRIMARY outcome

Timeframe: 2-year

Population: The number of subjects who came in for a 2 year visit and completed the x-ray portion of the evaluation.

Radiographic failure is defined as a complete radiolucent line \> 2mm wide at the bone/cement interface or a \>3 degree or \>3 mm migration (shift) of the component.

Outcome measures

Outcome measures
Measure	Primary 3DKnee Implant n=59 Participants Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.	0 participants

PRIMARY outcome

Timeframe: 2-year

Population: All subjects in the study were evaluated for adverse events.

Number of device related adverse events and device failures at the 2 year time frame.

Outcome measures

Outcome measures
Measure	Primary 3DKnee Implant n=71 Participants Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Safety Assessment Revisions of device	2 Events
Safety Assessment Number of device related adverse events	18 Events
Safety Assessment Total number of operative site events	40 Events

SECONDARY outcome

Timeframe: 2-year

Population: The number of subjects who completed an Oxford Knee score questionnaire at the 2 year visit.

Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.

Outcome measures

Outcome measures
Measure	Primary 3DKnee Implant n=59 Participants Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Oxford Knee Score	36.3 Units on a scale Standard Deviation 14.1

Adverse Events

Primary 3DKnee Implant

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Primary 3DKnee Implant n=71 participants at risk Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Blood and lymphatic system disorders Anemia	7.0% 5/71 • Number of events 5
Musculoskeletal and connective tissue disorders Arthrofibrosis	11.3% 8/71 • Number of events 8
Nervous system disorders Brain disorder	7.0% 5/71 • Number of events 5
Surgical and medical procedures Device Instability	4.2% 3/71 • Number of events 3
Endocrine disorders Diabetes	4.2% 3/71 • Number of events 3
Gastrointestinal disorders Diarrhea	2.8% 2/71 • Number of events 2
Blood and lymphatic system disorders Edema	2.8% 2/71 • Number of events 2
Musculoskeletal and connective tissue disorders Fracture	5.6% 4/71 • Number of events 5
Cardiac disorders Heart Complications	7.0% 5/71 • Number of events 5
Infections and infestations Wound infection, rash and/or redness	18.3% 13/71 • Number of events 13
Renal and urinary disorders Kidney disorder	2.8% 2/71 • Number of events 2
Injury, poisoning and procedural complications Nausea	2.8% 2/71 • Number of events 2
Nervous system disorders Numbness	8.5% 6/71 • Number of events 7
Musculoskeletal and connective tissue disorders Pain	53.5% 38/71 • Number of events 58
Vascular disorders Swelling	15.5% 11/71 • Number of events 12
Ear and labyrinth disorders Vertigo	2.8% 2/71 • Number of events 2
Renal and urinary disorders Urinary Tract Infection	4.2% 3/71 • Number of events 3

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