Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001025325p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
17/07/2026
Date registered
Help: Date registered
19/08/2026
Date last updated
Help: Date last updated
19/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
19/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of conjoint tendon release on pain and internal rotation following reverse total shoulder arthroplasty: a prospective randomised controlled trial
Scientific title
The effect of conjoint tendon release on pain and internal rotation following reverse total shoulder arthroplasty: a prospective randomised controlled trial
Additional trial identifiers [1] 317947 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Shoulder arthritis 342910 0
Reverse total shoulder arthroplasty 343146 0
Condition category
Condition code
Surgery 339022 339022 0 0
Surgical techniques
Musculoskeletal 339232 339232 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants in this study will be adults who are undergoing reverse total shoulder arthroplasty. The intervention is conjoint tendon release which will be performed at the same time and approach for the arthroplasty procedure.

The conjoint tendon is a tendon at the front of the shoulder which is comprised of the short head of biceps and coracobrachialis tendons and attaches to a bony structure on the shoulder blade (scapula) called the coracoid. A reverse total shoulder arthroplasty is an operation performed to replace the ball and socket of the shoulder joint and swaps the position of both. Recent evidence has shown that conjoint tendon irritation can cause stiffness and pain in patients undergoing reverse total shoulder arthroplasty, so a conjoint tendon release may help resolve this issue. Releasing the conjoint tendon involves incising it during the same initial operation for reverse shoulder arthroplasty to reduce the risk of stiffness and pain.

Conjoint tendon release will be performed in conjunction with the primary rTSA that patients will have already been planned for. This additional procedure does not require a separate surgical incision or approach, and should not significantly prolong the timing of surgery. The surgery will take approximately one hour and additional 20 minutes for conjoint tendon release. There are some theoretical risks which will be outlined below.
Surgical risks include: Anterior instability, potential neurovascular damage
Surgical technique of open conjoint tendon release does not require a new incision and it is completed within the existing anatomical field of the surgical approach. There is a theoretical risk of further bleeding and neurovascular injury from the extra procedure of incising the conjoint tendon such as musculocutaneous nerve. The operations will be performed by expert shoulder surgeons who will minimise such risk intraoperatively.

The main procedure to be performed for this study will be conjoint tendon release at coracoid insertion or not. Other procedures would include reverse total shoulder arthroplasty and follow up questionnaires and assessment. Follow up activities include clinical examination for range of motion (as part of normal follow up post operatively), questionnaires such as visual analogue scale for pain, SSV Subjective Shoulder Value, ASES American Shoulder and Elbow Society score. The hospital stay will be standard 1 night as per usual post op reverse total shoulder protocol, which may be dependent on patient comorbidities, discomfort and safety levels. This should not be altered by the conjoint tendon release. More detail about surgical approach is in the protocol

The intervention will be delivered once per participant in the randomised group. We are aiming for 80 participants so would be 40 interventions for this study. The study will be undertaken over a period of 2-5 years (depending on recruitment and participant numbers)

Confidentiality and integrity will be maintained by storing randomisation schedules in secure electronic systems with restricted access, excluding the outcome assessors. The hospital records will be used to monitor fidelity of the procedures.
Surgeons cannot be blinded but the patients and outcome assessors will be blinded to group allocation.
Intervention code [1] 334811 0
Treatment: Surgery
Description of the comparator or control
Control group will be reverse total shoulder arthroplasty without conjoint tendon release
Control group
Active

Outcomes
Primary outcome [1] 346263 0
Internal rotation
Timepoint [1] 346263 0
6 weeks, 3 months, 6 months and 12 months (primary timepoint) post reverse total shoulder arthroplasty surgery
Primary outcome [2] 346264 0
Anterior shoulder pain
Timepoint [2] 346264 0
6 weeks, 3 months, 6 months and 12 months (primary timepoint) post reverse total shoulder arthroplasty surgery
Secondary outcome [1] 465930 0
Patient satisfaction
Timepoint [1] 465930 0
6 weeks, 3 months, 6 months and 12 months (primary timepoint) post reverse total shoulder arthroplasty surgery

Eligibility
Key inclusion criteria
Patients undergoing primary rTSA for under two surgeons at Kareena Private Hospital and Strathfield Private Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Patients who have had rTSA performed for previously failed shoulder arthroplasty (revision procedure), prior coracoid surgery, active infection, pre-existing neuromuscular disorders, unwilling to participate in the trial, unable to provide informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur preoperatively after confirmation of eligibility. The allocation will be concealed in sealed opaque enveloped. The sequence will be generated by an independent statistician. Confidentiality and integrity will be maintained by storing randomisation schedules in secure electronic systems with restricted access, excluding the outcome assessors.
Surgeons cannot be blinded but the patients and outcome assessors will be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There will be a 1:1 allocation with a computer-generated random sequence with block randomisation.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2026
Actual
Date of last participant enrolment
Anticipated
28/08/2028
Actual
Date of last data collection
Anticipated
30/08/2029
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322495 0
Other Collaborative groups
Name [1] 322495 0
Orthocentre
Country [1] 322495 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Orthocentre
Address
Country
Australia
Secondary sponsor category [1] 325584 0
None
Name [1] 325584 0
Address [1] 325584 0
Country [1] 325584 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320974 0
Ramsay Health Care Human Research Ethics Committee A
Ethics committee address [1] 320974 0
Ethics committee country [1] 320974 0
Australia
Date submitted for ethics approval [1] 320974 0
23/03/2026
Approval date [1] 320974 0
Ethics approval number [1] 320974 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152254 0
Dr Sunna Bae
Address 152254 0
Orthocentre, 86 Kareena Road, Caringbah, 2229 NSW
Country 152254 0
Australia
Phone 152254 0
+61 2 9525 2055
Fax 152254 0
Email 152254 0
[email protected]
Contact person for public queries
Name 152255 0
Sunna Bae
Address 152255 0
Orthocentre, 86 Kareena Road, Caringbah, 2229 NSW
Country 152255 0
Australia
Phone 152255 0
+61 2 9525 2055
Fax 152255 0
Email 152255 0
[email protected]
Contact person for scientific queries
Name 152256 0
Sunna Bae
Address 152256 0
Orthocentre, 86 Kareena Road, Caringbah, 2229 NSW
Country 152256 0
Australia
Phone 152256 0
+61 2 9525 2055
Fax 152256 0
Email 152256 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Conjoint Tendon Release rTSA Protocol 003_clean.docx


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.