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NCT Number: NCT05788250

RC Repair Versus Subacromial Balloon Spacer in Older Adults

The purpose of this pilot study is to assess the feasibility of a full randomized trial design.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The feasibility objectives are:

  • Recruitment
  • To establish an estimate of the proportion of patients screened who are eligible for inclusion, and of those, the proportion who consent.
  • To establish an estimate of the proportion of eligible patients with medium/large tears versus massive tears.
  • Surgery -to confirm agreement among surgeons regarding the protocol's standardized surgical techniques of both groups.

Clinical objectives for observational purposes only are as follows:

  • Patient reported and clinical outcomes.
  • Number of "failures" in each group (defined as additional surgery and/or having <12% improvement in SANE score from baseline).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 70 years of age or older
  • clinical and radiological diagnosis of a full thickness supraspinatus (or larger) RC tear >2cm or more than 1 full tendon
  • ongoing symptoms after 3 months of physiotherapy
  • a tendon amenable to partial or complete repair (as determined by pre-operative MRI)
  • absence glenohumeral arthritis (Hamada < 3)
  • absence of neoplastic diseases at treated site

Exclusion criteria

  • previous surgery or pseudoparalysis on study shoulder
  • complete subscapularis deficiency
  • external rotation lag signs
  • avascular necrosis
  • post-infectious arthritis
  • proximal humerus fracture
  • inflammatory arithritis
  • axillary nerve palsy
  • concomitant tendon transfer
  • neuromuscular disorder
  • unable to speak/read English

Intra-operative Exclusion:

-tendon is NOT amenable to partial or complete repair

Treatment and study plan

Subacromial spacer implantation

Procedure

A biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps.

Rotator Cuff Repair

Procedure

Rotator cuff repair with tenotomy of long head of biceps.

Primary outcomes

  1. Study feasibility - randomized

    Time frame: 1 year

    Percentage of patients randomized

  2. Study feasibility - recruitment

    Time frame: 1 year

    Number of screened patients and proportion that are deemed eligible that consent

  3. Study feasibility - surgery

    Time frame: 1 year

    Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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)?"

  12. 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)?"

  13. 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)?"

  14. 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)?"

  15. 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)?"

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. Range of Motion

    Time frame: Baseline, pre-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.

  22. Range of Motion

    Time frame: 3 Months, post-oeprative

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

  23. 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.

  24. 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.

  25. Range of Motion

    Time frame: 24 Months, post-oeprative

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

  26. Isometric Strength

    Time frame: Baseline, pre-operative

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

  27. Isometric Strength

    Time frame: 3 Months, post-operative

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

  28. Isometric Strength

    Time frame: 6 Months, post-operative

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

  29. Isometric Strength

    Time frame: 12 Months, post-operative

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

  30. Isometric Strength

    Time frame: 24 Months, post-operative

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

Study contacts

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

Brenna Cyr, BKin

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 Rotator Cuff Repair (RCR) With Subacromial Balloon Spacer (SBS) Implantation

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 28, 2023
Registry last updated
Apr 2, 2024

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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