Scorpio NRG (eNeRGize) Cruciate Retaining (CR) Post-market International Outcome Study

• Sponsor: Stryker European Operations BV (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02524730
• Collaborator: (none)
• Enrollment: 205
• Locations: 5
• Arm: 1
• Actual Duration (Months): 128.8
• Patients Per Site: 41
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Knee	Device: Primary total knee replacement (Scorpio NRG CR Total Knee System)	N/A

Detailed Description

Evaluation of the effect of the component design on functional performance by comparing postoperative Knee Society Scores (KSS) with preoperative.

Evaluate post-operative radiographic findings. Evaluate the effect of component design on patient activity by comparing postoperative Lower Extremity Activity Scale (LEAS) with preoperative.

Evaluate patient satisfaction using Short-Form-36 Health Survey (SF-36). Evaluate quality of life using Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQuol-5 dimension patient questionaire (EQ-5D).

Study Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Scorpio NRG Prospective, Open-label, Post-market International Multicentre Outcome Study
• Actual Study Start Date: May 18, 2009
• Actual Primary Completion Date: Feb 10, 2020
• Actual Study Completion Date: Feb 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Scorpio NRG CR Total Knee System Primary total knee replacement	Device: Primary total knee replacement (Scorpio NRG CR Total Knee System); Scorpio NRG CR Total Knee System

Outcome Measures

Primary Outcome Measures

1. Survival Rate [7 year follow-up]

   Assess survival (absence of revision) at 7 year follow-up

Secondary Outcome Measures

1. Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) [Pre-operative, 3 months, 1, 3, 5 and optional 7 years]

   The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

2. Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire [Pre-operative, 3 months,1, 3, 5 and optional 7 years]

   The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.

3. Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) [Pre-operative, 3 months,1, 3, 5 and optional 7 years]

   The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores (physical function, physical role functioning, body pain, general health, vitality, social functioning, emotional role, mental health); each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

4. Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. [Pre-operative,1, 5 and optional 7 years]

   KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).

5. Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). [Pre-operative, 3 months,1, 3, 5 and optional 7 years]

   The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.

2. The subject is a male or non-pregnant female between 40 and 75 years of age.

3. The subject requires a primary total knee replacement.

4. Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid arthritis)

5. The subject has intact collateral ligaments.

6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

7. The subject is capable of understanding the patient scores in the national language.

Exclusion Criteria:

1. The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40.

2. The subject has a history of total or unicompartmental reconstruction of the affected joint.

3. The subject will be operated bilaterally.

4. Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study).

5. Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 months ago with good outcome can be included in the study).

6. Patients who will need lower limb joint replacement for another joint within one year.

7. The subject has had a high tibial osteotomy or femoral osteotomy.

8. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.

9. The subject has a systemic or metabolic disorder leading to progressive bone deterioration.

10. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements.

11. The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.

12. The subject has had a knee fusion to the affected joint.

13. The subject has an active or suspected latent infection in or about the knee joint.

14. Proven or suspected hypersensitivity to one or more than one of the device materials (see Appendix 10 table of chemical composition).

15. Female patients planning a pregnancy during the course of the study.

16. The subject is a prisoner.

17. severe deformities: varus/valgus deformity >10° (mech. axis), bowed femur > 20 degree, flexion contracture >10°

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University Hospital Innsbruck	Innsbruck	Tyrol	Austria	A-6020
2	Knappschaftskrankenhaus Dortmund	Dortmund	NRW	Germany	44309
3	Orthopaedische Maatschap Leeuwarden	Leeuwarden	Friesland	Netherlands	8934 AD
4	St. Antonius Ziekenhuis	Nieuwegein	Utrecht	Netherlands	3435 CM
5	Royal Devon and Exeter NHS Foundation Trust	Exeter	Devon	United Kingdom	EX2 5DW

Sponsors and Collaborators

• Stryker European Operations BV

Investigators

• Principal Investigator: Martin Krismer, Prof., Medical University Innsbruck

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 9, 2019

More Information

Publications

None provided.

• Responsible Party: Stryker European Operations BV
• ClinicalTrials.gov Identifier: NCT02524730
• Other Study ID Numbers: SLCRG-001-2007 / K-S-002
• First Posted: Aug 17, 2015
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

Participant Flow

Recruitment Details	205 participants who agreed to participate in the study following completion of the informed consent process were enrolled into the study

Arm/Group Title	Scorpio NRG CR Total Knee System
Arm/Group Description	Primary total knee replacement Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
Period Title: Overall Study
STARTED	205
COMPLETED	159
NOT COMPLETED	46

Baseline Characteristics

Arm/Group Title	Scorpio NRG CR Total Knee System
Arm/Group Description	Primary total knee replacement Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
Overall Participants	205
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.53 (6.5)
Sex: Female, Male (Count of Participants)
Female	132 64.4%
Male	72 35.1%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Europe	205 100%
Indication (participants) [Number]
Osteoarthritis	200 97.6%
Post-traumatic Arthritis	4 2%

Outcome Measures

1. Primary Outcome

Title	Survival Rate
Description	Assess survival (absence of revision) at 7 year follow-up
Time Frame	7 year follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Scorpio NRG CR Total Knee System
Arm/Group Description	Primary total knee replacement Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
Measure Participants	197
Femoral Component Revision	2 1%
Inlay Revision	1 0.5%
Tibial Tray Revision	1 0.5%
Total Knee Arthroplasty Revision	4 2%
No Revision	189 92.2%

2. Secondary Outcome

Title	Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Description	The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Time Frame	Pre-operative, 3 months, 1, 3, 5 and optional 7 years

Outcome Measure Data

Analysis Population Description

Numbers analyzed represent evaluable cases

Arm/Group Title	Scorpio NRG CR Total Knee System
Arm/Group Description	Primary total knee replacement Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
Measure Participants	204
Pre-operative pain motion score	57.84 (13.34)
Pain motion score at 3 months	78.71 (12.36)
Pain motion score at 1 year	83.27 (10.15)
Pain motion score at 3 years	83.85 (11.42)
Pain motion score at 5 years	84.73 (11.57)
Pain motion score at 7 years	84.20 (10.33)
Pre-operative function score	61.54 (17.78)
Function score at 3 months	78.05 (16.95)
Function score at 1 year	87.99 (15.68)
Function score at 3 years	85.00 (19.34)
Function score at 5 years	83.75 (19.75)
Function score at 7 years	83.51 (21.43)

3. Secondary Outcome

Title	Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
Description	The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time Frame	Pre-operative, 3 months,1, 3, 5 and optional 7 years

Outcome Measure Data

Analysis Population Description

Numbers analyzed represent evaluable cases.

Arm/Group Title	Scorpio NRG CR Total Knee System
Arm/Group Description	Primary total knee replacement Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
Measure Participants	205
pre-operative activity level	8.61 (2.51)
Activity level at 3 months	9.43 (2.81)
Activity level at 1 year	11.11 (3.06)
Activity level at 3 years	10.68 (3.00)
Activity level at 5 years	10.38 (3.09)
Activity level at 7 years	10.75 (3.20)

4. Secondary Outcome

Title	Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Description	The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores (physical function, physical role functioning, body pain, general health, vitality, social functioning, emotional role, mental health); each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time Frame	Pre-operative, 3 months,1, 3, 5 and optional 7 years

Outcome Measure Data

Analysis Population Description

Numbers analyzed represent evaluable cases.

Arm/Group Title	Scorpio NRG CR Total Knee System
Arm/Group Description	Primary total knee replacement Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
Measure Participants	205
Pre-operative physical function	30.62 (7.91)
Physical function at 3 months	40.2 (8.86)
Physical function at 1 year	44.67 (8.6)
Physical function at 3 years	43.97 (9.8)
Physical function at 5 years	42.41 (10.8)
Physical function at 7 years	43.07 (10.71)
Pre-operative physical role functioning	34.48 (9.19)
Physical role functioning at 3 months	39.04 (9.34)
Physical role functioning at 1 year	45.11 (9.77)
Physical role functioning at 3 years	44.0 (9.77)
Physical role functioning at 5 years	43.26 (10.75)
Physical role functioning at 7 years	43.65 (10.56)
Pre-operative body pain	42.24 (3.23)
Body pain at 3 months	40.69 (3.52)
Body pain at 1 year	39.72 (3.28)
Body pain at 3 years	39.47 (3.17)
Body pain at 5 years	39.48 (3.74)
Body pain at 7 years	39.35 (3.3)
Pre-operative general health	49.2 (8.15)
General health at 3 months	51.48 (7.57)
General health at 1 year	51.6 (8.28)
General health at 3 years	49.9 (8.38)
General health at 5 years	48.95 (9.02)
General health at 7 years	48.11 (8.82)
Pre-operative vitality	49.94 (8.61)
Vitality at 3 months	52.73 (8.93)
Vitality at 1 year	55.71 (9.4)
Vitality at 3 years	54.61 (9.46)
Vitality at 5 years	54.42 (8.56)
Vitality at 7 years	54.52 (9.38)
Pre-operative social functioning	44.67 (10.12)
Social functioning at 3 months	49.17 (8.91)
Social functioning at 1 year	51.16 (8.54)
Social functioning at 3 years	51.27 (8.26)
Social functioning at 5 years	50.83 (7.96)
Social functioning at 7 years	49.97 (8.98)
Pre-operative emotional role	43.41 (12.92)
Emotional role at 3 months	46.65 (11.65)
Emotional role at 1 year	47.81 (11.10)
Emotional role at 3 years	46.83 (10.81)
Emotional role at 5 years	47.47 (11.4)
Emotional role at 7 years	46.0 (11.78)
Pre-operative mental health	50.23 (9.4)
Mental health at 3 months	52.6 (9.86)
Mental health at 1 year	53.39 (9.96)
Mental health at 3 years	53.06 (8.80)
Mental health at 5 years	53.52 (8.63)
Mental health at 7 years	52.5 (9.36)

5. Secondary Outcome

Title	Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Description	KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Time Frame	Pre-operative,1, 5 and optional 7 years

Outcome Measure Data

Analysis Population Description

Numbers analyzed represent evaluable cases. The KOOS was collected pre-operatively and at 1, 5 and 7 years only.

Arm/Group Title	Scorpio NRG CR Total Knee System
Arm/Group Description	Primary total knee replacement Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
Measure Participants	202
Symptoms pre-operative	49.91 (18.55)
Symptoms at 1 year	79.58 (15.73)
Symptoms at 5 years	83.38 (16.1)
Symptoms at 7 years	85.83 (15.46)
Pain pre-operative	41.28 (17.82)
Pain at 1 year	82.9 (19.14)
Pain at 5 years	84.36 (19.38)
Pain at 7 years	86.99 (17.74)
Function, sports and recreation activities pre-operative	14.15 (16.26)
Function, sports and recreation activities at 1 year	47.89 (29.08)
Function, sports and recreation activities at 5 years	48.71 (31.05)
Function, sports and recreation activities at 7 years	52.79 (33.45)
Quality of life (QoL) pre-operative	24.36 (14.86)
QoL at 1 year	66.19 (24.11)
QoL at 5 years	66.78 (23.41)
QoL at 7 years	65.54 (21.81)
Function, daily living pre-operative	46.59 (18.2)
Function, daily living at 1 year	82.7 (17.35)
Function, daily living at 5 years	83.47 (18.46)
Function, daily living at 7 years	84.24 (19.23)

6. Secondary Outcome

Title	Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
Description	The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time Frame	Pre-operative, 3 months,1, 3, 5 and optional 7 years

Outcome Measure Data

Analysis Population Description

Numbers analyzed represent evaluable cases.

Arm/Group Title	Scorpio NRG CR Total Knee System
Arm/Group Description	Primary total knee replacement Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
Measure Participants	203
Pre-operative visual analogue scale (VAS)	70.97 (16.75)
VAS at 3 months	76.96 (13.92)
VAS at 1 year	77.41 (14.40)
VAS at 3 years	75.09 (14.11)
VAS at 5 years	76.84 (13.23)
VAS at 7 years	77.03 (14.77)
Pre-operative descriptive EQ-5D	0.55 (0.26)
Descriptive EQ-5D at 3 months	0.77 (0.17)
Descriptive EQ-5D at 1 year	0.84 (0.17)
Descriptive EQ-5D at 3 years	0.83 (0.19)
Descriptive EQ-5D at 5 years	0.82 (0.20)
Descriptive EQ-5D at 7 years	0.83 (0.19)

Adverse Events

Time Frame	Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
Arm/Group Title	Scorpio NRG CR Total Knee System
Arm/Group Description	Primary total knee replacement Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
All Cause Mortality
	Scorpio NRG CR Total Knee System
	Affected / at Risk (%)	# Events
Total	10/205 (4.9%)
Serious Adverse Events
	Scorpio NRG CR Total Knee System
	Affected / at Risk (%)	# Events
Total	88/205 (42.9%)
Cardiac disorders
Myocard infarction	7/205 (3.4%)	7
Heart valve disease	2/205 (1%)	2
Cardiovascular collapse	2/205 (1%)	2
Coronary artery disease	3/205 (1.5%)	3
Cehst pain	1/205 (0.5%)	1
Heart failure and dyspnea	1/205 (0.5%)	1
Gastrointestinal disorders
Diverticulitis	1/205 (0.5%)	1
Ileus	1/205 (0.5%)	1
General disorders
Suicide	1/205 (0.5%)	1
General health issues	1/205 (0.5%)	1
Death unknown cause	2/205 (1%)	2
Hepatobiliary disorders
Cholecystitis	1/205 (0.5%)	1
Hepatitis E	1/205 (0.5%)	1
Immune system disorders
Polyarteritis nodosa	1/205 (0.5%)	1
Infections and infestations
Pneumonia infections	4/205 (2%)	4
Deep joint infection	1/205 (0.5%)	1
pre-patellar bursitis	1/205 (0.5%)	1
Injury, poisoning and procedural complications
head/spinal cord trauma	2/205 (1%)	2
Wound dehiscence/hematoma	2/205 (1%)	2
Musculoskeletal and connective tissue disorders
Quadriceps tendon rupture	1/205 (0.5%)	2
Inlay wear	1/205 (0.5%)	1
Instability	2/205 (1%)	2
Aseptic loosening	2/205 (1%)	2
Post cruciate ligament rupture	2/205 (1%)	2
Great toe surgery	3/205 (1.5%)	4
Retropatellar arthritis	2/205 (1%)	2
Arthrofibrosis	5/205 (2.4%)	6
Shoulder tendon rupture	1/205 (0.5%)	1
Carpal tunnel syndrome	1/205 (0.5%)	1
Hemarthrosis	1/205 (0.5%)	1
Elbow fracture	1/205 (0.5%)	1
Per-trochanteric fracture	1/205 (0.5%)	1
Knee pain	1/205 (0.5%)	1
Ankle arthrosis	1/205 (0.5%)	1
Patella subluxation	1/205 (0.5%)	1
Adhesion	1/205 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	17/205 (8.3%)	18
Nervous system disorders
Dementia	1/205 (0.5%)	1
Product Issues
Fraxiparine allergy	1/205 (0.5%)	1
Renal and urinary disorders
Kidney stone	1/205 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
COPD	1/205 (0.5%)	1
Skin and subcutaneous tissue disorders
Necrotic wound	1/205 (0.5%)	1
Surgical and medical procedures
Posterior intervaginal plasty	1/205 (0.5%)	1
Vascular disorders
Pulmonary embolism	1/205 (0.5%)	1
Stroke	2/205 (1%)	2
Other (Not Including Serious) Adverse Events
	Scorpio NRG CR Total Knee System
	Affected / at Risk (%)	# Events
Total	15/205 (7.3%)
Musculoskeletal and connective tissue disorders
Knee pain	15/205 (7.3%)	15

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.