ShapeMatch Cutting Guide Functional Outcomes Study

A Prospective, Randomized, Multi-centre Study of the Triathlon Cruciate Retaining Total Knee System Using ShapeMatch Cutting Guides

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02539992

Acronym

ShapeMatch

Enrollment

Registered

2015-09-03

Start date

2012-05-31

Completion date

2015-05-31

Last updated

2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee

Brief summary

Randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria.

Detailed description

This study will be a prospective, randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria. Forty-eight cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. Another forty-eight cases enrolled will receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. And the last forty-eight cases will receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment.

Interventions

DEVICETriathlon® CR/Kinematic Alignment

Total knee replacement using patient-specific cutting guides

DEVICETriathlon® CR/Neutral Overall Limb Alignment

Total knee replacement using patient-specific cutting guides

DEVICETriathlon® CR/Conventional Limb Alignment

Total knee replacement using traditional instrumentation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Patient has signed an ethic commission approved study specific Informed Patient Consent Form. 2. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation. 3. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). 4. Patient is a candidate for a primary total knee replacement. 5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion criteria

1. Patient has a Body Mass Index (BMI) ≥ 40. 2. Patient age ≥ 80. 3. Patient has a varus or valgus deformity greater than 10 degree or flexion contracture greater than 20 degree. 4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation. 5. Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year. 6. Patient requires bilateral total knee replacements, or has a history of contralateral partial or total knee replacement. 7. Patient has any implanted device that would be incompatible with MRI procedures. 8. Patient has chronic heart failure (NYHA Stage ≥ 2) 9. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. 10. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Pagets Disease) leading to progressive bone deterioration. 11. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). 12. Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint. 13. Patient has a known sensitivity to device materials. 14. Patient is a prisoner.

Design outcomes

Primary

Measure	Time frame	Description
Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.	6 months	To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment.

Secondary

Measure	Time frame	Description
Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test	1 year	Get-up-and-go test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. One source suggests that scores of ten seconds or less indicate normal mobility, 11 - 20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.	1 year follow-up	The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100. High scores indicate good outcome, i.e., a high degree of being able to forget about the affected joint in daily life.
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.	1 year follow-up	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).
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).	1 year follow-up	The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).	1 year follow-up	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.
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).	1 year follow-up	The EQ-5D index has an upper bound equal to 1 that indicates full health (indicated by no problem in all domains), whereas 0 represents death. Negative values are allowed, and the lower bound varies depending on country-specific value set used. UK time Trade Off (UKTTO) indicates the patient status compared to the normal state of the UK population.

Countries

Germany, Italy, United Kingdom

Participant flow

Recruitment details

56 patients have been screened for study participation. No patient withdrew his/her informed consent.

Pre-assignment details

12/56 patients received another procedure. Therefore 44 patients were enrolled in 4 centers.

Participants by arm

Arm	Count
Triathlon® CR/Kinematic Alignment Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides	15
Triathlon® CR/Neutral Overall Limb Alignment Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides	11
Triathlon® CR/Conventional Limb Alignment Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee. Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation	18
Total	44

Baseline characteristics

Characteristic	Triathlon® CR/Kinematic Alignment	Triathlon® CR/Neutral Overall Limb Alignment	Triathlon® CR/Conventional Limb Alignment	Total
Age, Continuous	69 years STANDARD_DEVIATION 5.8	67 years STANDARD_DEVIATION 9.3	70 years STANDARD_DEVIATION 4.8	69 years STANDARD_DEVIATION 6.4
Region of Enrollment Germany	3 participants	3 participants	2 participants	8 participants
Region of Enrollment Italy	11 participants	7 participants	12 participants	30 participants
Region of Enrollment United Kingdom	1 participants	1 participants	4 participants	6 participants
Sex: Female, Male Female	9 Participants	7 Participants	10 Participants	26 Participants
Sex: Female, Male Male	6 Participants	4 Participants	8 Participants	18 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 15	0 / 11	0 / 18
serious Total, serious adverse events	1 / 15	4 / 11	2 / 18

Outcome results

Primary

Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.

To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment.

Time frame: 6 months

Population: Early study termination resulted in limited availability of data for analysis to provide robust, meaningful results. Therefore the fluoroscopic data sets of the Neutral Overall Limb Alignment and Conventional Limb Alignment groups were combined and compared with the Kinematic Alignment group.

Arm	Measure	Group	Value (MEAN)	Dispersion
Triathlon® CR/Kinematic Alignment	Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.	Contact Point Rotation (CPR) Stair Climbing	7.3 Degrees	Standard Deviation 3.5
Triathlon® CR/Kinematic Alignment	Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.	CPR Chair Rising	12.6 Degrees	Standard Deviation 2.6
Triathlon® CR/Kinematic Alignment	Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.	CPR Extension-Against-Gravity	12.5 Degrees	Standard Deviation 4.2
Triathlon® CR/Neutral Overall Limb Alignment	Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.	Contact Point Rotation (CPR) Stair Climbing	8.2 Degrees	Standard Deviation 3.2
Triathlon® CR/Neutral Overall Limb Alignment	Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.	CPR Chair Rising	10.2 Degrees	Standard Deviation 3.7
Triathlon® CR/Neutral Overall Limb Alignment	Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.	CPR Extension-Against-Gravity	8.8 Degrees	Standard Deviation 5.3

Secondary

Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).

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: 1 year follow-up