Reverse Shoulder ArthroplastyNCT04728282
Comparison of Lateralized RTSA With and Without Subscapularis Repair
A study testing RTSA with subscapularis repair and RTSA without subscapularis repair in people with Reverse Shoulder Arthroplasty, run by Panam Clinic at 6 sites in Canada.
Trial summary
The purpose of this double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern "lateralized" implant over the course of 24-months postoperative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reverse Shoulder Arthroplasty
- What is being tested?
- RTSA with subscapularis repair and RTSA without subscapularis repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 6 sitesCanada
- Study dates
- 1 Nov 2021to 1 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with surgeon-patient decision to undergo RTSA
- First RTSA implantation
- Absence of neoplastic diseases at the treated site
- Fatty infiltration of the subscapularis is low-grade (i.e. Goutallier < Grade 3) based on pre-operative CT performed as standard of care in the patient group
Who cannot join
- Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
- Avascular necrosis
- Post-infectious arthritis
- Proximal humerus fracture
- Inflammatory arthritis
- Inability to communicate in English
Show all 11Show fewer
- Unable to return for study visits to 24-months post-operative (e.g. unable to arrange transportation to study appointments, plans to relocate, etc.)
- Intra-operative Exclusions:
- Subscapularis with fatty infiltration (Goutallier ≥ 3)
- Subscapularis that is deemed to be irreparable. An irreparable tendon is defined as one that is not of sufficient quality or does not allow adequate excursion to reach the repair site
- Any anatomical or patient characteristic that warrants a non-lateralized implant
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Not yet recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Danielle Dagher, 905-522-1155 ext. 32953, ddagher@stjoes.ca
Moin Khan
- Not yet recruiting
Fraser Orthopaedic Institute
New Westminster, British Columbia, V3L 0E4
Manuja Annthakumar, 604-553-3247, manuja.annthakumar@fraserhealth.ca
Farhad Moola
- Not yet recruiting
The Ottawa Hospital
Ottawa, Ontario
Katie McIlquham, 613-737-8899 ext. 79839, kmciquham@ohri.ca
Peter Lapner, MD
- Not yet recruiting
Saint John Orthopaedics
Saint John, New Brunswick
Dresden Forshner, 506-566-2515, dresden.forshner@horizonNB.ca
Eva Gusnowski, MD
- Not yet recruiting
University of British Columbia
Vancouver
Manuja Annthakumar, 778-945-6756, manuja.annthakumar@vch.ca
Alex Hoffer, MD
- Recruiting
Pan Am Clinic
Winnipeg, Manitoba, R3M 3E4
Heather Normand, 204-925-7469, hnormand3@panamclinic.com
Jarret Woodmass, MD
About this study
Official title: Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair
The purpose of this double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern "lateralized" implant over the course of 24-months postoperative.
Read the detailed description
The main objective of this study is to compare patient-reported outcome measures (PROMs), and clinical and functional outcomes between RTSA with and without subscapularis repair. The specific aims for this study are:
Specific Aim 1:
To determine if there is a difference in PROM scores between RTSA with and without subscapularis repair during the 24-month postoperative period.
Specific Aim 2:
To determine if there is a difference between the two surgical approaches with respect to shoulder function, specifically range of motion and strength, during the 24-month postoperative period.
Specific Aim 3:
To determine if there is a difference in shoulder dislocation rates between RTSA with and without subscapularis repair during the 24-month postoperative period.
Specific Aim 4:
To determine if there is a difference in surgical complications, re-operation or revision rates between RTSA with and without subscapularis repair during the 24-month postoperative period.
Specific Aim 5:
To quantify the operative times for RTSA with and without subscapularis repair, and determine if there is a difference between the two approaches.
- Conditions
- Reverse Shoulder Arthroplasty
- Being tested
- RTSA with subscapularis repair, RTSA without subscapularis repair
- Keywords
- reverse total shoulder arthroplasty, subscapularis, repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTSA with subscapularis repairProcedure or surgery
Lateralized reverse total shoulder arthroplasty with repair of subscapularis
RTSA without subscapularis repairProcedure or surgery
Lateralized reverse total shoulder arthroplasty without repair of subscapularis
| Study group | Role | What they receive |
|---|---|---|
| RTSA with subscapularis repair | Experimental | Not described Receives: Procedure: RTSA with subscapularis repair |
| RTSA without subscapularis repair | Active comparator | Not described Receives: Procedure: RTSA without subscapularis repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASES Score
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America.
Measured: 24 months post-operative
Secondary outcomes (29)
Constant Score
The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant \& Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome.
Measured: baseline pre-operative
Constant Score
The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant \& Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome.
Measured: 3 months post-operative
Constant Score
The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant \& Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome.
Measured: 6 months post-operative
Constant Score
The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant \& Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome.
Measured: 12 months post-operative
Constant Score
The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant \& Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome.
Measured: 24 months post-operative
SANE Score
The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019). Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Measured: baseline pre-operative
SANE Score
The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019). Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Measured: 3 months post-operative
SANE Score
The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019). Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Measured: 6 months post-operative
SANE Score
The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019). Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Measured: 12 months post-operative
SANE Score
The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019). Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Measured: 24 months post-operative
EQ5D-3L
The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011). A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population. There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive. The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
Measured: baseline, pre-operative
EQ5D-3L
The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011). A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population. There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive. The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
Measured: 3 months, post-operative
EQ5D-3L
The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011). A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population. There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive. The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
Measured: 6 months, post-operative
EQ5D-3L
The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011). A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population. There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive. The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
Measured: 12 months, post-operative
EQ5D-3L
The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011). A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population. There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive. The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
Measured: 24 months, post-operative
Range of Motion
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Measured: baseline, pre-surgery
Range of Motion
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Measured: 3 months, post-operative
Range of Motion
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Measured: 6 months, post-operative
Range of Motion
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Measured: 12 months, post-operative
Range of Motion
For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
Measured: 24 months, post-operative
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation
Measured: baseline, pre-surgery
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation
Measured: 3 months, post-operative
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation
Measured: 6 months, post-operative
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation
Measured: 12 months, post-operative
Isometric Strength
Measured using a hand-held dynamometer, in flexion, abduction, and external rotation
Measured: 24 months, post-operative
ASES Score
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America.
Measured: baseline, pre-operative
ASES Score
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America.
Measured: 3 months, post-operative
ASES Score
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America.
Measured: 6 months, post-operative
ASES Score
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America.
Measured: 12 months, post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Nov 2021
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reverse Shoulder ArthroplastyStudies of the same condition, open and under way.
- 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
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blinded randomized clinical trial comparing two groups, RTSA with and RTSA without subscapularis repair. Eighty-four participants will be randomized at a 1:1 ratio in blocks of 12. All participants will be recruited from the patient populations of six fellowship trained upper extremity orthopaedic surgeons at initial consult. Patients will be randomized intraoperatively using a telephone/web-based system.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Sponsor
- Investigators
- Jarret Woodmass, MD, Principal investigator, Pan Am Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728282
- Sponsor's protocol ID
- RSASUB-16-01-2021
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair
- ClinicalTrials.gov ID
- NCT04728282
- Acronym / sponsor ID
- RSASUB-16-01-2021
- Conditions
- Reverse Shoulder Arthroplasty
- Keywords
- reverse total shoulder arthroplasty, subscapularis, repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
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 double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern "lateralized" implant over the course of 24-months postoperative.
Detailed description
The main objective of this study is to compare patient-reported outcome measures (PROMs), and clinical and functional outcomes between RTSA with and without subscapularis repair. The specific aims for this study are:
Specific Aim 1:
To determine if there is a difference in PROM scores between RTSA with and without subscapularis repair during the 24-month postoperative period.
Specific Aim 2:
To determine if there is a difference between the two surgical approaches with respect to shoulder function, specifically range of motion and strength, during the 24-month postoperative period.
Specific Aim 3:
To determine if there is a difference in shoulder dislocation rates between RTSA with and without subscapularis repair during the 24-month postoperative period.
Specific Aim 4:
To determine if there is a difference in surgical complications, re-operation or revision rates between RTSA with and without subscapularis repair during the 24-month postoperative period.
Specific Aim 5:
To quantify the operative times for RTSA with and without subscapularis repair, and determine if there is a difference between the two approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-blinded randomized clinical trial comparing two groups, RTSA with and RTSA without subscapularis repair. Eighty-four participants will be randomized at a 1:1 ratio in blocks of 12. All participants will be recruited from the patient populations of six fellowship trained upper extremity orthopaedic surgeons at initial consult. Patients will be randomized intraoperatively using a telephone/web-based system.
| Arm | Type | Receives |
|---|---|---|
| RTSA with subscapularis repair | Experimental | Procedure: RTSA with subscapularis repair |
| RTSA without subscapularis repair | Active comparator | Procedure: RTSA without subscapularis repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with surgeon-patient decision to undergo RTSA
- First RTSA implantation
- Absence of neoplastic diseases at the treated site
- Fatty infiltration of the subscapularis is low-grade (i.e. Goutallier < Grade 3) based on pre-operative CT performed as standard of care in the patient group
Key exclusion criteria (11 listed)
- Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
- Avascular necrosis
- Post-infectious arthritis
- Proximal humerus fracture
- Inflammatory arthritis
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 |
|---|---|---|
| RTSA with subscapularis repairLateralized reverse total shoulder arthroplasty with repair of subscapularis | Procedure or surgery | RTSA with subscapularis repair |
| RTSA without subscapularis repairLateralized reverse total shoulder arthroplasty without repair of subscapularis | Procedure or surgery | RTSA without subscapularis repair |
Primary outcome
ASES Score
Time frame: 24 months post-operative
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America.
29 secondary outcomes
Constant Score
Time frame: baseline pre-operative
Constant Score
Time frame: 3 months post-operative
Constant Score
Time frame: 6 months post-operative
Constant Score
Time frame: 12 months post-operative
Constant Score
Time frame: 24 months post-operative
SANE Score
Time frame: baseline pre-operative
SANE Score
Time frame: 3 months post-operative
SANE Score
Time frame: 6 months post-operative
SANE Score
Time frame: 12 months post-operative
SANE Score
Time frame: 24 months post-operative
EQ5D-3L
Time frame: baseline, pre-operative
EQ5D-3L
Time frame: 3 months, post-operative
EQ5D-3L
Time frame: 6 months, post-operative
EQ5D-3L
Time frame: 12 months, post-operative
EQ5D-3L
Time frame: 24 months, post-operative
Range of Motion
Time frame: baseline, pre-surgery
Range of Motion
Time frame: 3 months, post-operative
Range of Motion
Time frame: 6 months, post-operative
Range of Motion
Time frame: 12 months, post-operative
Range of Motion
Time frame: 24 months, post-operative
Isometric Strength
Time frame: baseline, pre-surgery
Isometric Strength
Time frame: 3 months, post-operative
Isometric Strength
Time frame: 6 months, post-operative
Isometric Strength
Time frame: 12 months, post-operative
Isometric Strength
Time frame: 24 months, post-operative
ASES Score
Time frame: baseline, pre-operative
ASES Score
Time frame: 3 months, post-operative
ASES Score
Time frame: 6 months, post-operative
ASES Score
Time frame: 12 months, post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Jarret Woodmass, MD principal investigator
Pan Am Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RTSA with subscapularis repair and RTSA without subscapularis repair in people with Reverse Shoulder Arthroplasty, run by Panam Clinic at 6 sites in Canada.
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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Normand (204-925-7469, hnormand3@panamclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES Score (time frame: 24 months post-operative). 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 27 Oct 2026.