Trial Outcomes & Findings for Atlas Knee System Clinical System Clinical Study (USA) (NCT NCT02934659)
NCT ID: NCT02934659
Last Updated: 2026-06-26
Results Overview
1. WOMAC pain questions in the KOOS questionnaire (20% and 10 point improvement from baseline) 2. WOMAC function questions in the KOOS questionnaire (20% and 10 point improvement from baseline) 3. Maintenance of normal range of motion (ROM, knee flexion \>=90 degrees and knee extension within 10 degrees of neutral) 4. No subsequent surgical intervention of the medial knee; and no serious device-related adverse events 5. Maintenance of implant integrity as evaluated by radiographic assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Change at 24 months relative to baseline
Results posted on
2026-06-26
Participant Flow
Up to 50 subjects will be enrolled in this study at up to 10 investigational sites.
All subjects included in this investigation were asked to return for follow up visits at 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months, then annually for 5 years. Subjects that underwent an implant removal were asked to continue participation and complete questionnaires at 6 months, at 1 and 2 year post explant procedure.
Participant milestones
| Measure |
Atlas Knee System
Intervention - Atlas Knee System device for medial knee osteoarthritis Atlas™ Knee System: The Atlas System is an extra-capsular knee implant designed to unload the medial knee.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atlas Knee System Clinical System Clinical Study (USA)
Baseline characteristics by cohort
| Measure |
Atlas Knee System
n=50 Participants
Intervention - Atlas Knee System device for medial knee osteoarthritis
|
|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 10.87 • n=20 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
BMI (kg/m^2)
|
28.8 kg/m^2
STANDARD_DEVIATION 3.57 • n=20 Participants
|
PRIMARY outcome
Timeframe: Change at 24 months relative to baselinePopulation: Results are presented such that the rate is the number of subjects that successfully met the condition. Performance data is summarized using descriptive statistics. Statistical Imputation was used for any missing data.
1. WOMAC pain questions in the KOOS questionnaire (20% and 10 point improvement from baseline) 2. WOMAC function questions in the KOOS questionnaire (20% and 10 point improvement from baseline) 3. Maintenance of normal range of motion (ROM, knee flexion \>=90 degrees and knee extension within 10 degrees of neutral) 4. No subsequent surgical intervention of the medial knee; and no serious device-related adverse events 5. Maintenance of implant integrity as evaluated by radiographic assessment.
Outcome measures
| Measure |
Atlas Knee System
n=50 Participants
Intervention - Atlas Knee System device for medial knee osteoarthritis Atlas Knee System: The Atlas System is an extra-capsular knee implant designed to unload the medial knee.
|
|---|---|
|
The Primary Endpoint of This Pilot Study is the Number of Subjects Who Were Deemed a Success for Each of the Following Measures at 24 Months.
WOMAC Pain
|
43 Participants
|
|
The Primary Endpoint of This Pilot Study is the Number of Subjects Who Were Deemed a Success for Each of the Following Measures at 24 Months.
WOMAC Function
|
41 Participants
|
|
The Primary Endpoint of This Pilot Study is the Number of Subjects Who Were Deemed a Success for Each of the Following Measures at 24 Months.
Range of Motion
|
50 Participants
|
|
The Primary Endpoint of This Pilot Study is the Number of Subjects Who Were Deemed a Success for Each of the Following Measures at 24 Months.
Device-Related SAEs / Intervention
|
34 Participants
|
|
The Primary Endpoint of This Pilot Study is the Number of Subjects Who Were Deemed a Success for Each of the Following Measures at 24 Months.
Implant Integrity
|
38 Participants
|
Adverse Events
Atlas Knee System
Serious events: 21 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atlas Knee System
n=50 participants at risk
Intervention - Atlas Knee System device for medial knee osteoarthritis
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Related: Implant failed to improve OA symptoms
|
6.0%
3/50 • Number of events 3 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Inflammation - Soft tissue
|
2.0%
1/50 • Number of events 1 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Knee pain
|
2.0%
1/50 • Number of events 1 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Knee scarring, arthrofibrosis, peri-prosthetic local adhesions, or excessive scar tissue
|
2.0%
1/50 • Number of events 1 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Pain and swelling with soft tissue irritation
|
2.0%
1/50 • Number of events 1 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Trauma to knee (i.e. fall)
|
2.0%
1/50 • Number of events 1 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Product Issues
Related: Mechanical failure of device or components
|
18.0%
9/50 • Number of events 9 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Vascular disorders
Related: Thrombosis - Pulmonary Embolus
|
2.0%
1/50 • Number of events 1 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Exacerbation of OA
|
2.0%
1/50 • Number of events 1 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Unrelated: Exacerbation of OA
|
8.0%
4/50 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Unrelated: Trauma to Knee (i.e. fall)
|
2.0%
1/50 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Unrelated: Inflammation - Soft tissue
|
2.0%
1/50 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Skin and subcutaneous tissue disorders
Unrelated: Allergic reaction
|
2.0%
1/50 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Cardiac disorders
Unrelated: Atrial Fibrillation
|
2.0%
1/50 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Gastrointestinal disorders
Unrelated: Gastrointestinal Event
|
2.0%
1/50 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Unrelated: Injury
|
2.0%
1/50 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
Other adverse events
| Measure |
Atlas Knee System
n=50 participants at risk
Intervention - Atlas Knee System device for medial knee osteoarthritis
|
|---|---|
|
Product Issues
Related: Mechanical failure of device or components
|
6.0%
3/50 • Number of events 3 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Irritation related to rehabilitation or surgical recovery
|
8.0%
4/50 • Number of events 4 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Unrelated: Exacerbation of OA
|
10.0%
5/50 • Number of events 5 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Unrelated: Fracture
|
8.0%
4/50 • Number of events 4 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Gastrointestinal disorders
Unrelated: Gastrointestinal Event
|
6.0%
3/50 • Number of events 3 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Unrelated: Inflammation - Soft tissue
|
6.0%
3/50 • Number of events 3 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Unrelated: Study Knee Pain
|
8.0%
4/50 • Number of events 4 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
General disorders
Unrelated: Non Study Knee Pain
|
28.0%
14/50 • Number of events 21 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Unrelated: Trauma to knee (i.e. fall)
|
12.0%
6/50 • Number of events 6 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Respiratory, thoracic and mediastinal disorders
Unrelated: Upper Respiratory Event
|
12.0%
6/50 • Number of events 7 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Inflammation - Bursitis
|
8.0%
4/50 • Number of events 4 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Inflammation - Soft tissue
|
12.0%
6/50 • Number of events 8 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Knee scarring, arthrofibrosis, peri-prosthetic local adhesions, or excessive scar tissue
|
8.0%
4/50 • Number of events 4 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Nerve irritation
|
12.0%
6/50 • Number of events 7 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
|
Musculoskeletal and connective tissue disorders
Related: Soft tissue irritation
|
14.0%
7/50 • Number of events 7 • Adverse Events collected from enrollment through 24 months.
Adverse Events related to treatment and unrelated to treatment as reported by the investigational site are included.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution agrees the study is a multi-center study conducted by Sponsor and not to publish results until completion of a publication in a journal, unless authorized by Sponsor. Thereafter, Institution may publish its site experience, but Sponsor reserves the exclusive right to publish results, and to establish authorship based on compliance, contribution to study and acceptance of author responsibilities. If not submitted within 12 months of study closure, Institution may Publish.
- Publication restrictions are in place
Restriction type: OTHER