Trial Outcomes & Findings for nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis (NCT NCT02610192)

NCT ID: NCT02610192

Last Updated: 2020-06-12

Results Overview

The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: Baseline, 1, 3, 6 and 12 Months
• Results posted on: 2020-06-12

Participant Flow

The study is conducted at a single center in Deurne (Belgium).

Participant milestones

Measure	nSTRIDE APS Intra-articular Injection of Autologous Protein Solution (APS)
Overall Study STARTED	50
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	nSTRIDE APS Intra-articular Injection of Autologous Protein Solution (APS)
Overall Study Received other treatment	8
Overall Study Physician Decision	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	nSTRIDE APS n=50 Participants Intra-articular Injection of Autologous Protein Solution (APS)
Age, Customized Age	50.4 years STANDARD_DEVIATION 6.5 • n=50 Participants
Sex/Gender, Customized Gender (female)	50 participants n=50 Participants
Region of Enrollment Belgium	50 participants n=50 Participants

PRIMARY outcome

Timeframe: Baseline, 1, 3, 6 and 12 Months

Population: Analyses were performed on available data, with no imputation for missing data.

The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems.

Outcome measures

Measure	nSTRIDE APS n=50 Participants Intra-articular Injection of Autologous Protein Solution (APS)
Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months 3-Months	52.5 score on a scale Standard Deviation 24.1
Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months 6-Months	54.9 score on a scale Standard Deviation 22.6
Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months Baseline	40.3 score on a scale Standard Deviation 18.7
Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months 1-Month	53.5 score on a scale Standard Deviation 19.8
Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months 12-Months	57.3 score on a scale Standard Deviation 24.8

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6 and 12 Months

Population: Analyses were performed on available data, with no imputation for missing data.

The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems

Outcome measures

Measure	nSTRIDE APS n=50 Participants Intra-articular Injection of Autologous Protein Solution (APS)
Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months Baseline	46.9 score on a scale Standard Deviation 18.4
Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months 1-Months	59.2 score on a scale Standard Deviation 19.2
Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months 3-Months	61.4 score on a scale Standard Deviation 21.6
Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months 6-Months	61.5 score on a scale Standard Deviation 18.8
Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months 12-Months	62.5 score on a scale Standard Deviation 22.1

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6 and 12 Months

Population: Analyses were performed on available data, with no imputation for missing data.

The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems

Outcome measures

Measure	nSTRIDE APS n=50 Participants Intra-articular Injection of Autologous Protein Solution (APS)
Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months Baseline	45.9 score on a scale Standard Deviation 21.1
Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months 1-Months	58.8 score on a scale Standard Deviation 21.9
Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months 3-Months	57.9 score on a scale Standard Deviation 26.8
Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months 6-Months	59.7 score on a scale Standard Deviation 22.8
Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months 12-Months	62.0 score on a scale Standard Deviation 24.2

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6 and 12 Months

Population: Analyses were performed on available data, with no imputation for missing data.

The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems

Outcome measures

Measure	nSTRIDE APS n=50 Participants Intra-articular Injection of Autologous Protein Solution (APS)
Function in Sport and Recreation (Sport/Rec) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Sport/Rec at 1, 3, 6 and 12 Months Baseline	11.2 score on a scale Standard Deviation 13.6
Function in Sport and Recreation (Sport/Rec) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Sport/Rec at 1, 3, 6 and 12 Months 1-Months	23.0 score on a scale Standard Deviation 20.1
Function in Sport and Recreation (Sport/Rec) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Sport/Rec at 1, 3, 6 and 12 Months 3-Months	20.8 score on a scale Standard Deviation 20.2
Function in Sport and Recreation (Sport/Rec) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Sport/Rec at 1, 3, 6 and 12 Months 6-Months	22.4 score on a scale Standard Deviation 23.7
Function in Sport and Recreation (Sport/Rec) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Sport/Rec at 1, 3, 6 and 12 Months 12-Months	22.9 score on a scale Standard Deviation 24.3

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6 and 12 Months

Population: Analyses were performed on available data, with no imputation for missing data.

The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems

Outcome measures

Measure	nSTRIDE APS n=50 Participants Intra-articular Injection of Autologous Protein Solution (APS)
Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months Baseline	29.7 score on a scale Standard Deviation 10.7
Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months 1-Months	37.5 score on a scale Standard Deviation 12.1
Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months 3-Months	37.0 score on a scale Standard Deviation 11.8
Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months 6-Months	36.3 score on a scale Standard Deviation 13.6
Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months 12-Months	38.2 score on a scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6 and 12 Months

Population: Analyses were performed on available data, with no imputation for missing data.

The NRS is a validated measure of pain, stiffness and function. The NRS is an 11 point Likert type scale anchored by 0 "no pain" and 10 "worst possible pain". Subjects rate their average pain over the last 24 hours. Likewise subjects rate their stiffness and function on an 11 point Likert type scale

Outcome measures

Measure	nSTRIDE APS n=50 Participants Intra-articular Injection of Autologous Protein Solution (APS)
Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months Baseline	6.7 score on a scale Standard Deviation 2.2
Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months 1-Months	4.9 score on a scale Standard Deviation 2.5
Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months 3-Months	5.0 score on a scale Standard Deviation 2.9
Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months 6-Months	4.7 score on a scale Standard Deviation 2.8
Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months 12-Months	4.5 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6 and 12 Months

Population: Analyses were performed on available data, with no imputation for missing data.

The NRS is a validated measure of pain, stiffness and function. The NRS is an 11 point Likert type scale anchored by 0 "no pain" and 10 "worst possible pain". Subjects rate their average pain over the last 24 hours. Likewise subjects rate their stiffness and function on an 11 point Likert type scale

Outcome measures

Measure	nSTRIDE APS n=50 Participants Intra-articular Injection of Autologous Protein Solution (APS)
Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months Baseline	6.0 score on a scale Standard Deviation 2.6
Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months 1-Months	4.3 score on a scale Standard Deviation 2.8
Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months 3-Months	4.5 score on a scale Standard Deviation 3.1
Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months 6-Months	4.1 score on a scale Standard Deviation 2.8
Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months 12-Months	4.0 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6 and 12 Months

Population: Analyses were performed on available data, with no imputation for missing data.

The NRS is a validated measure of pain, stiffness and function. The NRS is an 11 point Likert type scale anchored by 0 "no pain" and 10 "worst possible pain". Subjects rate their average pain over the last 24 hours. Likewise subjects rate their stiffness and function on an 11 point Likert type scale

Outcome measures

Measure	nSTRIDE APS n=50 Participants Intra-articular Injection of Autologous Protein Solution (APS)
Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months 6-Months	4.7 score on a scale Standard Deviation 2.7
Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months Baseline	6.6 score on a scale Standard Deviation 2.1
Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months 1-Months	4.9 score on a scale Standard Deviation 2.4
Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months 3-Months	4.7 score on a scale Standard Deviation 2.7
Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months 12-Months	4.4 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6 and 12 Months

Population: Analyses were performed on available data, with no imputation for missing data.

The KAKPAQ is a 13-item screening instrument designed to assess patellofemoral pain and instability in adolescents and young adults, with a variable ordinal response format (3-5 choices). The questions included knee functional ability; limping, weight bearing, walking, stairs, squatting, running, jumping, prolonged sitting, pain swelling, painful patellar movement, muscle atrophy and flexion deficiency. Each answer had different scores. To calculate the total score, all items were summarized. The score '0' represented the greatest limitation of knee function, whereas the score '100' indicated the ability to perform most knee functions

Outcome measures

Measure	nSTRIDE APS n=50 Participants Intra-articular Injection of Autologous Protein Solution (APS)
Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months Baseline	48.4 score on a scale Standard Deviation 13.0
Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months 1-Months	55.4 score on a scale Standard Deviation 16.3
Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months 3-Months	54.8 score on a scale Standard Deviation 17.0
Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months 6-Months	57.0 score on a scale Standard Deviation 17.0
Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months 12-Months	56.3 score on a scale Standard Deviation 18.1

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6 and 12 Months

Population: Analyses were performed on available data, with no imputation for missing data.

The UCLA Activity Score is a validated measure of subject activity. Subjects rate their current activity level from on a simple scale ranging from 1 to 10. The subject indicated her or his most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports

Outcome measures

Measure	nSTRIDE APS n=50 Participants Intra-articular Injection of Autologous Protein Solution (APS)
Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months Baseline	5.0 score on a scale Standard Deviation 1.9
Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months 1-Months	5.3 score on a scale Standard Deviation 1.7
Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months 3-Months	5.5 score on a scale Standard Deviation 2.0
Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months 6-Months	5.2 score on a scale Standard Deviation 1.8
Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months 12-Months	5.6 score on a scale Standard Deviation 1.9

Adverse Events

nSTRIDE APS

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	nSTRIDE APS n=50 participants at risk Intra-articular Injection of Autologous Protein Solution (APS)
Musculoskeletal and connective tissue disorders Knee Pain	6.0% 3/50 • Number of events 3 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol

Other adverse events

Measure	nSTRIDE APS n=50 participants at risk Intra-articular Injection of Autologous Protein Solution (APS)
Musculoskeletal and connective tissue disorders Excessive Injection Site Pain	6.0% 3/50 • Number of events 3 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders Increased Knee Pain	60.0% 30/50 • Number of events 41 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders Knee Effusion	30.0% 15/50 • Number of events 16 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders pain in calf	2.0% 1/50 • Number of events 1 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders Sprain muscle leg	2.0% 1/50 • Number of events 1 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders burning feeling lower limb-foot	2.0% 1/50 • Number of events 1 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Neoplasms benign, malignant and unspecified (incl cysts and polyps) kahler disease	2.0% 1/50 • Number of events 1 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders Stifness	12.0% 6/50 • Number of events 8 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders fall on knee causing pain	6.0% 3/50 • Number of events 3 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders inflammation pes anserinus	2.0% 1/50 • Number of events 1 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders knee twist causing medial bone edema	2.0% 1/50 • Number of events 1 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders Knee overload	2.0% 1/50 • Number of events 1 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders Pain meniscus	2.0% 1/50 • Number of events 1 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders pain on the medial side due medial root tear	2.0% 1/50 • Number of events 1 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders worsening OA symptoms	2.0% 1/50 • Number of events 1 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Musculoskeletal and connective tissue disorders wrong movement causing knee pain	2.0% 1/50 • Number of events 1 • month 1, month 3, month 6 and month 12 Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol

Additional Information

Mr. Cahit Akbas

Zimmer Biomet

Phone: +31622981737

Email: Cahit.Akbas@zimmerbiomet.com

Results disclosure agreements

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

Restriction type: LTE60