Stability, functional and clinical outcomes following Reverse Total Shoulder Arthroplasty (RSA); Repair versus Non-Repair of the Subscapularis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12616000864426

Enrollment

Registered

2016-07-01

Start date

2016-07-18

Completion date

2016-12-14

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The importance of the subscapularis in patients with a Reverse Shoulder Arthroplasty prosthesis and consequently, the need of repair following implantation, remains controversial. The aim of the study is to determine the stability, functional and clinical outcomes of a repaired versus non-repaired/irreparable subscapularis following Reverse Total Shoulder Arthroplasty. The primary objective of this study is to assess the difference in the function, as measured by the self-reported ASES score, between two RSA treatment groups up to 5 years post-surgery. Secondary objectives are to: Compare outcomes of patients implanted with a medialised versus lateralised Reverse Total Shoulder prosthesis between the two treatment groups. Consider the influence of scar tissue development on functional and clinical outcomes between the two treatment groups. A physiotherapy focused substudy will evaluate the intra- and inter-rater reliability of range of motion (ROM), manual muscle testing (MMT) and hand held dynamometry (HHD) strength testing for assessment of Reverse Total Shoulder Arthroplasty patients.

Interventions

Patients undergoing Reverse Shoulder Arthroplasty (RSA) using the deltopectoral approach require the release of the subscapularis either via tenotomy or lesser tuberosity osteotomy. The importance of the subscapularis in patients with a RSA prosthesis and consequently, the need of repair following implantation, remains controversial. The exposure of interest is Subscapularis repair compared to non-repair following RSA. The duration of follow-up period is designed for a single assessment session in which the clinical, functional and radiographic assessments will be conducted. Assessments will require approximately two hours to complete, occurring at any point between surgery and 5 years post surgery. The two hours may be spread of over multiple visits depending on the participant's and health professionals availability.

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

Patient has provided written, informed consent and is willing to participant. Participant is a male or non-pregnant female, at least 40 years old, and preferably at least 50 years of age. Patient has received a Reverse Total Shoulder Replacement implanted within the previous 5 years.

Exclusion criteria

Patient has undergone Revision reverse shoulder arthroplasty (i.e. previous resurfacing, hemi, total or reverse).

Outcome results