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NCT Number: NCT04728282

Comparison of Lateralized 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location status: Recruiting

Location contact

Sheila McRae, PhD

CONTACT

[email protected]

204-925-7469

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
  • Avascular necrosis
  • Post-infectious arthritis
  • Proximal humerus fracture
  • Inflammatory arthritis
  • Inability to communicate in English
  • 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

Treatment and study plan

RTSA with subscapularis repair

Procedure

Lateralized reverse total shoulder arthroplasty with repair of subscapularis

RTSA without subscapularis repair

Procedure

Lateralized reverse total shoulder arthroplasty without repair of subscapularis

Primary outcomes

  1. 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.

Secondary outcomes

  1. Constant Score

    Time frame: baseline pre-operative

    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.

  2. Constant Score

    Time frame: 3 months post-operative

    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.

  3. Constant Score

    Time frame: 6 months post-operative

    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.

  4. Constant Score

    Time frame: 12 months post-operative

    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.

  5. Constant Score

    Time frame: 24 months post-operative

    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.

  6. SANE Score

    Time frame: baseline pre-operative

    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)?"

  7. SANE Score

    Time frame: 3 months post-operative

    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)?"

  8. SANE Score

    Time frame: 6 months post-operative

    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)?"

  9. SANE Score

    Time frame: 12 months post-operative

    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)?"

  10. SANE Score

    Time frame: 24 months post-operative

    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)?"

  11. EQ5D-3L

    Time frame: baseline, pre-operative

    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.

  12. EQ5D-3L

    Time frame: 3 months, post-operative

    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.

  13. EQ5D-3L

    Time frame: 6 months, post-operative

    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.

  14. EQ5D-3L

    Time frame: 12 months, post-operative

    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.

  15. EQ5D-3L

    Time frame: 24 months, post-operative

    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.

  16. Range of Motion

    Time frame: baseline, pre-surgery

    For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.

  17. Range of Motion

    Time frame: 3 months, post-operative

    For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.

  18. Range of Motion

    Time frame: 6 months, post-operative

    For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.

  19. Range of Motion

    Time frame: 12 months, post-operative

    For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.

  20. Range of Motion

    Time frame: 24 months, post-operative

    For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.

  21. Isometric Strength

    Time frame: baseline, pre-surgery

    Measured using a hand-held dynamometer, in flexion, abduction, and external rotation

  22. Isometric Strength

    Time frame: 3 months, post-operative

    Measured using a hand-held dynamometer, in flexion, abduction, and external rotation

  23. Isometric Strength

    Time frame: 6 months, post-operative

    Measured using a hand-held dynamometer, in flexion, abduction, and external rotation

  24. Isometric Strength

    Time frame: 12 months, post-operative

    Measured using a hand-held dynamometer, in flexion, abduction, and external rotation

  25. Isometric Strength

    Time frame: 24 months, post-operative

    Measured using a hand-held dynamometer, in flexion, abduction, and external rotation

  26. ASES Score

    Time frame: baseline, pre-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.

  27. ASES Score

    Time frame: 3 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.

  28. ASES Score

    Time frame: 6 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. ASES Score

    Time frame: 12 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Derek McLennan, BSc

CONTACT

[email protected]

204-927-2828

Sheila McRae, PhD

CONTACT

[email protected]

204-925-7469

Sponsors and collaborators

Lead sponsor

Panam Clinic

Other

Collaborators

  • University of Manitoba

Registry information

Official study title

Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Jan 28, 2021
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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