Clinical trial NCT04728282: Comparison of Lateralized RTSA With and Without Subscapularis Repair
Official title: Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Arthritis Shoulder
Keywords: reverse total shoulder arthroplasty
subscapularis
repair
Lead sponsor: Panam Clinic
Sponsor class: OTHER
Collaborators: name: University of Manitoba
First posted: 2021-01-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ASES Score
timeFrame: 24 months post-operative
Secondary outcomes:
measure: Constant Score
timeFrame: baseline pre-operative
measure: Constant Score
timeFrame: 3 months post-operative
measure: Constant Score
timeFrame: 6 months post-operative
measure: Constant Score
timeFrame: 12 months post-operative
measure: Constant Score
timeFrame: 24 months post-operative
measure: SANE Score
timeFrame: baseline pre-operative
measure: SANE Score
timeFrame: 3 months post-operative
measure: SANE Score
timeFrame: 6 months post-operative
measure: SANE Score
timeFrame: 12 months post-operative
measure: SANE Score
timeFrame: 24 months post-operative
measure: EQ5D-3L
timeFrame: baseline, pre-operative
measure: EQ5D-3L
timeFrame: 3 months, post-operative
measure: EQ5D-3L
timeFrame: 6 months, post-operative
measure: EQ5D-3L
timeFrame: 12 months, post-operative
measure: EQ5D-3L
timeFrame: 24 months, post-operative
measure: Range of Motion
timeFrame: baseline, pre-surgery
measure: Range of Motion
timeFrame: 3 months, post-operative
measure: Range of Motion
timeFrame: 6 months, post-operative
measure: Range of Motion
timeFrame: 12 months, post-operative
measure: Range of Motion
timeFrame: 24 months, post-operative
measure: Isometric Strength
timeFrame: baseline, pre-surgery
measure: Isometric Strength
timeFrame: 3 months, post-operative
measure: Isometric Strength
timeFrame: 6 months, post-operative
measure: Isometric Strength
timeFrame: 12 months, post-operative
measure: Isometric Strength
timeFrame: 24 months, post-operative
measure: ASES Score
timeFrame: baseline, pre-operative
measure: ASES Score
timeFrame: 3 months, post-operative
measure: ASES Score
timeFrame: 6 months, post-operative
measure: ASES Score
timeFrame: 12 months, post-operative
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
Study officials:
affiliation: Pan Am Clinic
name: Jarret Woodmass, MD
role: PRINCIPAL_INVESTIGATOR
References: