Back to resultsAequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty (PYC)
Primary Purpose
Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
Aequalis Pyrocarbon Humeral Head
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria: Adult subject 22 years or older. Scapula and proximal humerus must have reached skeletal maturity. Clinical indication for hemiarthroplasty due to primary diagnosis of arthritis or avascular necrosis. Primary arthritis for this study includes osteoarthritis with pain and/or post-traumatic arthritis. Willing and able to comply with the protocol. Willing and able to sign the informed consent formed (or the Legally Authorized Representative will sign for the subject). Exclusion Criteria: Active local or systemic infection, sepsis, or osteomyelitis. In the opinion of the clinician, there is insufficient bone stock to support implants in the humeral metaphysis or poor bone quality. In the opinion of the clinician, there is insufficient bone stock or excessive deformation of the native glenoid to allow normal functioning of the glenohumeral joint. In the clinician's opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional. Metabolism disorders that could compromise bone formation, or Osteomalacia. Infection at or near the implant site, distant foci of infections that could spread to the site of the implant, or systemic infection. Rapid destruction of the joint, marked bone loss, or bone resorption apparent on X-ray. Known allergy or suspected allergy to implant materials. Female subjects who are pregnant or planning to become pregnant within the study period. Medical conditions or balance impairments that could lead to falls. Prior arthroplasty or prior failed rotator cuff repair on the affected shoulder; (successful rotator cuff surgery may be included). A rotator cuff that is not intact and cannot be reconstructed. Subjects with a massive rotator cuff tear (>5cm) will be excluded. Nonfunctional deltoid muscle. Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint). Known active metastatic or neoplastic diseases, Paget's disease, or Charcot's disease. Currently, within the last 6 months, or planning to be on chemotherapy or radiation. Known alcohol or drug abuse as defined by DSM-5. Taking greater than 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery. Currently enrolled in any clinical research study that might interfere with the current study endpoints. Known history of renal or hepatic disease/insufficiency. Anatomy cannot be replicated using current available system sizes.
Sites / Locations
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hemi Shoulder Arthroplasty
Arm Description
Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head
Outcomes
Primary Outcome Measures
Rate of Patient Success at 24 Months.
A subject is a success at 24 months if:
Their change in Constant score is greater than or equal to 17 and
They did not have revision surgery; and
There is no radiographic evidence of system disassembly or fracture, and
They did not have a system-related serious adverse event.
Secondary Outcome Measures
Constant Score
Constant Score: In this score, 35 points are allocated for subjective assessments of pain and activities of daily living and 65 points are available for objective measures of range of movement and shoulder strength. A young healthy patient can therefore have a maximum score of 100 points. The minimum score is 0 points. The range of the score is 0-100 for both the Constant Score and the adjusted Constant score. A higher value represents a better outcome.
Average of 2 pain scores (15 points max) Sum of 4 activities of daily living questions (20 points max) Sum of 4 ROM measure (40 points max) Power score (25 points max)
Change in Constant Score and Adjusted Constant Score at 24 months compared to baseline is presented along with absolute values.
American Shoulder and Elbow Surgeons (ASES) Score
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment. The original ASES consists of 2 portions, a medical professional assessment section and a patient self-report section. The patient self-report section utilized in this study is a condition specific scale intended to measure functional limitations and pain of the shoulder. The assessment takes approximately 5 minutes to complete and consists of 2 dimensions: pain and activities of daily living. The pain score is calculated from the single pain question and the function score from the sum of the 10 questions addressing function. The pain score and function composite score are weighted equally (50 points each) and combined for a total score out of a possible 100 points. The minimum score is 0 and the maximum score is 100. A higher value represents a better outcome.
Change in American Shoulder and Elbow Surgeons (ASES) Score at 24 months compared to baseline are presented.
Single Assessment Numeric Evaluation (SANE)
The SANE rating is determined by the subject's written response to the following question "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Change in Single Assessment Numeric Evaluation (SANE) at 24 months compared to baseline
EQ-5D Index
EQ-5D: a standardized instrument for use as a measure of health outcome. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for health status. Scale 0 to 1; 1 (representing full health) to 0 (representing dead).
Change in EQ-5D score at 24 months compared to baseline
Pain Measured by a VIsual Analog Scale (VAS)
Pain is measured by a visual analog scale (from 0-10). The subject responds to the question: How bad is your pain TODAY. 0 is no pain; 10 is pain as bad as it can be.
Change in pain measured by a visual analog scale (VAS) at 24 months compared to baseline
Range of Motion (ROM)
Range of Motion (ROM) is a movement test conducted on a joint to diagnose level of pain and function. The shoulder joint has a greater Range of Motion than all other joints in the body. In this study, ROM was measured using a goniometer for forward flexion in relation to the thorax, abduction, and external rotation (arm at side and arm abducted to 90°).
Change in Range of Motion (ROM) at 24 months compared to baseline.
Forward Flexion
Abduction
External Rotation
Strength
The subject's strength will be assessed using a fixed force gauge. The fixed force gauge is held in place by the examiner and the subject pulls upward with maximum effort for approximately five seconds. The test can be completed up to three times and the maximum score is used, however all three pulls will be recorded. The test is done only on the affected arm. The result of this test contributes to the Constant score calculation.
Change in Strength testing at 24 months compared to baseline
Number of Participants With Device-related Serious Adverse Events
Adverse Events data will be collected and summarized at 24 months.
Revision Rate
A revision is a procedure that adjusts or in any way modifies or removes any component of the original implant configuration, with or without replacement of a component, after the initial surgery. A revision may also include adjusting the position of the original configuration. An explant is a revision that includes permanent removal of any system component. If a subject has a revision that includes an addition of a glenoid component (revision to TSA) the Pyrocarbon humeral head must be permanently explanted.
The Revision Rate will be calculated and summarized at 24 months.
Level of Satisfaction With the Shoulder
The level of satisfaction with the shoulder will be summarized at 24 months.
X-Ray Data
The follow data will be summarized at 24 Months:
glenohumeral joint space width, glenoid osteophytes, glenoid morphology, humeral component radiolucency, osteolysis, migration, subsidence, subluxation, acromial humeral distance, anatomic fracture, and additional observations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02525783
Brief Title
Aequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty
Acronym
PYC
Official Title
Aequalis Pyrocarbon Humeral Head IDE Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 19, 2019 (Actual)
Study Completion Date
October 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Trauma GmbH
4. Oversight
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to demonstrate safety and effectiveness of the Aequalis Pyrocarbon Humeral Head in hemiarthroplasty at 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
7. Study Design
Primary Purpose
Treatment
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemi Shoulder Arthroplasty
Arm Type
Experimental
Arm Description
Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head
Intervention Type
Device
Intervention Name(s)
Aequalis Pyrocarbon Humeral Head
Intervention Description
Hemi Shoulder Arthroplasty
Primary Outcome Measure Information:
Title
Rate of Patient Success at 24 Months.
Description
A subject is a success at 24 months if:
Their change in Constant score is greater than or equal to 17 and
They did not have revision surgery; and
There is no radiographic evidence of system disassembly or fracture, and
They did not have a system-related serious adverse event.
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Constant Score
Description
Constant Score: In this score, 35 points are allocated for subjective assessments of pain and activities of daily living and 65 points are available for objective measures of range of movement and shoulder strength. A young healthy patient can therefore have a maximum score of 100 points. The minimum score is 0 points. The range of the score is 0-100 for both the Constant Score and the adjusted Constant score. A higher value represents a better outcome.
Average of 2 pain scores (15 points max) Sum of 4 activities of daily living questions (20 points max) Sum of 4 ROM measure (40 points max) Power score (25 points max)
Change in Constant Score and Adjusted Constant Score at 24 months compared to baseline is presented along with absolute values.
Time Frame
24 Months
Title
American Shoulder and Elbow Surgeons (ASES) Score
Description
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment. The original ASES consists of 2 portions, a medical professional assessment section and a patient self-report section. The patient self-report section utilized in this study is a condition specific scale intended to measure functional limitations and pain of the shoulder. The assessment takes approximately 5 minutes to complete and consists of 2 dimensions: pain and activities of daily living. The pain score is calculated from the single pain question and the function score from the sum of the 10 questions addressing function. The pain score and function composite score are weighted equally (50 points each) and combined for a total score out of a possible 100 points. The minimum score is 0 and the maximum score is 100. A higher value represents a better outcome.
Change in American Shoulder and Elbow Surgeons (ASES) Score at 24 months compared to baseline are presented.
Time Frame
24 Months
Title
Single Assessment Numeric Evaluation (SANE)
Description
The SANE rating is determined by the subject's written response to the following question "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Change in Single Assessment Numeric Evaluation (SANE) at 24 months compared to baseline
Time Frame
24 Months
Title
EQ-5D Index
Description
EQ-5D: a standardized instrument for use as a measure of health outcome. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for health status. Scale 0 to 1; 1 (representing full health) to 0 (representing dead).
Change in EQ-5D score at 24 months compared to baseline
Time Frame
24 Months
Title
Pain Measured by a VIsual Analog Scale (VAS)
Description
Pain is measured by a visual analog scale (from 0-10). The subject responds to the question: How bad is your pain TODAY. 0 is no pain; 10 is pain as bad as it can be.
Change in pain measured by a visual analog scale (VAS) at 24 months compared to baseline
Time Frame
24 Months
Title
Range of Motion (ROM)
Description
Range of Motion (ROM) is a movement test conducted on a joint to diagnose level of pain and function. The shoulder joint has a greater Range of Motion than all other joints in the body. In this study, ROM was measured using a goniometer for forward flexion in relation to the thorax, abduction, and external rotation (arm at side and arm abducted to 90°).
Change in Range of Motion (ROM) at 24 months compared to baseline.
Forward Flexion
Abduction
External Rotation
Time Frame
24 Months
Title
Strength
Description
The subject's strength will be assessed using a fixed force gauge. The fixed force gauge is held in place by the examiner and the subject pulls upward with maximum effort for approximately five seconds. The test can be completed up to three times and the maximum score is used, however all three pulls will be recorded. The test is done only on the affected arm. The result of this test contributes to the Constant score calculation.
Change in Strength testing at 24 months compared to baseline
Time Frame
24 Months
Title
Number of Participants With Device-related Serious Adverse Events
Description
Adverse Events data will be collected and summarized at 24 months.
Time Frame
24 Months
Title
Revision Rate
Description
A revision is a procedure that adjusts or in any way modifies or removes any component of the original implant configuration, with or without replacement of a component, after the initial surgery. A revision may also include adjusting the position of the original configuration. An explant is a revision that includes permanent removal of any system component. If a subject has a revision that includes an addition of a glenoid component (revision to TSA) the Pyrocarbon humeral head must be permanently explanted.
The Revision Rate will be calculated and summarized at 24 months.
Time Frame
24 Months
Title
Level of Satisfaction With the Shoulder
Description
The level of satisfaction with the shoulder will be summarized at 24 months.
Time Frame
24 Months
Title
X-Ray Data
Description
The follow data will be summarized at 24 Months:
glenohumeral joint space width, glenoid osteophytes, glenoid morphology, humeral component radiolucency, osteolysis, migration, subsidence, subluxation, acromial humeral distance, anatomic fracture, and additional observations
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult subject 22 years or older.
Scapula and proximal humerus must have reached skeletal maturity.
Clinical indication for hemiarthroplasty due to primary diagnosis of arthritis or avascular necrosis. Primary arthritis for this study includes osteoarthritis with pain and/or post-traumatic arthritis.
Willing and able to comply with the protocol.
Willing and able to sign the informed consent formed (or the Legally Authorized Representative will sign for the subject).
Exclusion Criteria:
Active local or systemic infection, sepsis, or osteomyelitis.
In the opinion of the clinician, there is insufficient bone stock to support implants in the humeral metaphysis or poor bone quality.
In the opinion of the clinician, there is insufficient bone stock or excessive deformation of the native glenoid to allow normal functioning of the glenohumeral joint.
In the clinician's opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional.
Metabolism disorders that could compromise bone formation, or Osteomalacia.
Infection at or near the implant site, distant foci of infections that could spread to the site of the implant, or systemic infection.
Rapid destruction of the joint, marked bone loss, or bone resorption apparent on X-ray.
Known allergy or suspected allergy to implant materials.
Female subjects who are pregnant or planning to become pregnant within the study period.
Medical conditions or balance impairments that could lead to falls. Prior arthroplasty or prior failed rotator cuff repair on the affected shoulder; (successful rotator cuff surgery may be included).
A rotator cuff that is not intact and cannot be reconstructed. Subjects with a massive rotator cuff tear (>5cm) will be excluded.
Nonfunctional deltoid muscle.
Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint).
Known active metastatic or neoplastic diseases, Paget's disease, or Charcot's disease.
Currently, within the last 6 months, or planning to be on chemotherapy or radiation.
Known alcohol or drug abuse as defined by DSM-5.
Taking greater than 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
Currently enrolled in any clinical research study that might interfere with the current study endpoints.
Known history of renal or hepatic disease/insufficiency.
Anatomy cannot be replicated using current available system sizes.
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available to other researchers. Only aggregate data will be shared with the researchers.
Learn more about this trial
Aequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty
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