OsteoarthritisPYCNCT02525783
Aequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty
A study testing Aequalis Pyrocarbon Humeral Head in people with Osteoarthritis and Avascular Necrosis, run by Stryker Trauma and Extremities at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate safety and effectiveness of the Aequalis Pyrocarbon Humeral Head in hemiarthroplasty at 24 months. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
- What is being tested?
- Aequalis Pyrocarbon Humeral Head
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 7 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aequalis Pyrocarbon Humeral Head IDE Study
The purpose of this study is to demonstrate safety and effectiveness of the Aequalis Pyrocarbon Humeral Head in hemiarthroplasty at 24 months.
- Conditions
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
- Being tested
- Aequalis Pyrocarbon Humeral Head
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aequalis Pyrocarbon Humeral HeadDevice
Hemi Shoulder Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Hemi Shoulder Arthroplasty | Experimental | Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head Receives: Device: Aequalis Pyrocarbon Humeral Head |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Months
Secondary outcomes (11)
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.
Measured: 24 Months
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.
Measured: 24 Months
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
Measured: 24 Months
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
Measured: 24 Months
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
Measured: 24 Months
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
Measured: 24 Months
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
Measured: 24 Months
Number of Participants With Device-related Serious Adverse Events
Adverse Events data will be collected and summarized at 24 months.
Measured: 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.
Measured: 24 Months
Level of Satisfaction With the Shoulder
The level of satisfaction with the shoulder will be summarized at 24 months.
Measured: 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
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startDec 2015
- Primary completion19 Jul 2019
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525783
- Sponsor's protocol ID
- 15A-T-PYC-R
- Acronym
- PYC
- Status last verified
- Dec 2022
- First submitted
- 14 Aug 2015
- Last updated
- 19 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers. Only aggregate data will be shared with the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aequalis Pyrocarbon Humeral Head IDE Study
- ClinicalTrials.gov ID
- NCT02525783
- Acronym / sponsor ID
- PYC / 15A-T-PYC-R
- Conditions
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Posted 19 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate safety and effectiveness of the Aequalis Pyrocarbon Humeral Head in hemiarthroplasty at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemi Shoulder Arthroplasty | Experimental | Device: Aequalis Pyrocarbon Humeral HeadHemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aequalis Pyrocarbon Humeral HeadHemi Shoulder Arthroplasty | Device | Hemi Shoulder Arthroplasty |
Primary outcome
Rate of Patient Success at 24 Months.
Time frame: 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.
11 secondary outcomes
Constant Score
Time frame: 24 Months
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: 24 Months
Single Assessment Numeric Evaluation (SANE)
Time frame: 24 Months
EQ-5D Index
Time frame: 24 Months
Pain Measured by a VIsual Analog Scale (VAS)
Time frame: 24 Months
Range of Motion (ROM)
Time frame: 24 Months
Strength
Time frame: 24 Months
Number of Participants With Device-related Serious Adverse Events
Time frame: 24 Months
Revision Rate
Time frame: 24 Months
Level of Satisfaction With the Shoulder
Time frame: 24 Months
X-Ray Data
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers. Only aggregate data will be shared with the researchers.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aequalis Pyrocarbon Humeral Head in people with Osteoarthritis and Avascular Necrosis, run by Stryker Trauma and Extremities at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Patient Success at 24 Months. (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.