The 3DKnee™ System: A Post-Market Study

• Sponsor: Encore Medical, L.P. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00764673
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Arm: 1
• Duration (Months): 48
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™ system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic implant in the knee. Each knee will be designated as a separate subject and followed for a period of 2 years.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis; Varus Deformity; Avascular Necrosis	Device: 3DKnee	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The 3DKnee™ System: A Post-Market Study
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Primary Post market study	Device: 3DKnee; Subjects with knee osteoarthritis and willing to participate in the study

Outcome Measures

Primary Outcome Measures

1. Knee Society Score Evaluation [2 year]

   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).

2. Knee Society Function Score [2-year]

   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.

3. Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component. [2-year]

   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.

4. Safety Assessment [2-year]

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

Secondary Outcome Measures

1. Oxford Knee Score [2-year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• This must be a primary knee replacement on this knee.

• Have knee joint disease related to one or more of the following

• degenerative joint disease, including osteoarthritis or traumatic arthritis

• Avascular necrosis of the femoral condyles

• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy

• Moderate valgus, varus, or flexion deformities

• Rheumatoid arthritis

• Patient is likely to be available for evaluation for the duration of the study

• Able and willing to sign the informed consent and follow study procedures

• Patient is not pregnant

• Patient must be over 18 years of age

Exclusion Criteria:

• If there has been a total knee replacement on this knee in the past (no revisions allowed in study)

• Infection, or history of infection, acute or chronic, local or systemic

• Alcoholism or other addictions

• Muscular, neurological or vascular deficiencies which compromise the affected extremity

• Obesity

• Insufficient bone quality

• Loss of ligamentous structures

• High levels of physical activity

• Materials sensitivity

• Prisoner

• Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements

• Patient is pregnant

• Is younger than 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Peter's Bone & Joint Surgery	St. Peters	Missouri	United States	63376

Sponsors and Collaborators

• Encore Medical, L.P.

Investigators

• Principal Investigator: John McAllister, M.D., St. Peter's Bone and Joint Surgery

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor Company home page

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00764673
• Other Study ID Numbers: PS - 703
• First Posted: Oct 2, 2008
• Last Update Posted: Mar 2, 2011
• Last Verified: Feb 1, 2011

• Additional relevant MeSH terms: Arthritis; Necrosis

Study Results

Participant Flow

Arm/Group Title	Primary 3DKnee Implant
Arm/Group Description	Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Period Title: Overall Study
STARTED	71
COMPLETED	59
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Primary 3DKnee Implant
Arm/Group Description	Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Overall Participants	71
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	25 35.2%
>=65 years	46 64.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69 (8.7)
Sex: Female, Male (Count of Participants)
Female	49 69%
Male	22 31%
Region of Enrollment (participants) [Number]
United States	71 100%
Operated Knee (participants) [Number]
Right knee	36 50.7%
Left knee	35 49.3%
Primary Diagnosis (participants) [Number]
Osteoarthritis	69 97.2%
Varus deformity	1 1.4%
Post-traumatic arthritis	1 1.4%

Outcome Measures

1. Primary Outcome

Title	Knee Society Score Evaluation
Description	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).
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

The number of subjects who completed their 2 year visit.

Arm/Group Title	Primary 3DKnee Implant
Arm/Group Description	Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Measure Participants	59
Mean (Standard Deviation) [Average Knee Rating Score]	82.9 (25.7)

2. Primary Outcome

Title	Knee Society Function Score
Description	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.
Time Frame	2-year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Primary 3DKnee Implant
Arm/Group Description	Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Measure Participants	54
Mean (Standard Deviation) [Average Knee Function Score]	76.6 (20.0)

3. Secondary Outcome

Title	Oxford Knee Score
Description	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.
Time Frame	2-year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Primary 3DKnee Implant
Arm/Group Description	Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Measure Participants	59
Mean (Standard Deviation) [Units on a scale]	36.3 (14.1)

4. Primary Outcome

Title	Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.
Description	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.
Time Frame	2-year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Primary 3DKnee Implant
Arm/Group Description	Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Measure Participants	59
Number [participants]	0 0%

5. Primary Outcome

Title	Safety Assessment
Description	Number of device related adverse events and device failures at the 2 year time frame.
Time Frame	2-year

Outcome Measure Data

Analysis Population Description

All subjects in the study were evaluated for adverse events.

Arm/Group Title	Primary 3DKnee Implant
Arm/Group Description	Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
Measure Participants	71
Revisions of device	2
Number of device related adverse events	18
Total number of operative site events	40

Adverse Events

Arm/Group Title	Primary 3DKnee Implant
Arm/Group Description	Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
All Cause Mortality
	Primary 3DKnee Implant
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Primary 3DKnee Implant
	Affected / at Risk (%)	# Events
Total	0/71 (0%)
Other (Not Including Serious) Adverse Events
	Primary 3DKnee Implant
	Affected / at Risk (%)	# Events
Total	62/71 (87.3%)
Blood and lymphatic system disorders
Anemia	5/71 (7%)	5
Edema	2/71 (2.8%)	2
Cardiac disorders
Heart Complications	5/71 (7%)	5
Ear and labyrinth disorders
Vertigo	2/71 (2.8%)	2
Endocrine disorders
Diabetes	3/71 (4.2%)	3
Gastrointestinal disorders
Diarrhea	2/71 (2.8%)	2
Infections and infestations
Wound infection, rash and/or redness	13/71 (18.3%)	13
Injury, poisoning and procedural complications
Nausea	2/71 (2.8%)	2
Musculoskeletal and connective tissue disorders
Arthrofibrosis	8/71 (11.3%)	8
Fracture	4/71 (5.6%)	5
Pain	38/71 (53.5%)	58
Nervous system disorders
Brain disorder	5/71 (7%)	5
Numbness	6/71 (8.5%)	7
Renal and urinary disorders
Kidney disorder	2/71 (2.8%)	2
Urinary Tract Infection	3/71 (4.2%)	3
Surgical and medical procedures
Device Instability	3/71 (4.2%)	3
Vascular disorders
Swelling	11/71 (15.5%)	12

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.