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Trial registered on ANZCTR


Registration number
ACTRN12624001357549p
Ethics application status
Not yet submitted
Date submitted
21/10/2024
Date registered
13/11/2024
Date last updated
13/11/2024
Date data sharing statement initially provided
13/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Arthroscopic rotator cuff repair with leukocyte poor platelets rich plasma or concentrated bone marrow aspirate. A Prospective Randomized Controlled Trial.
Scientific title
The effect of orthobiologic augmentation on arthroscopic rotator cuff repair with leukocyte poor platelets rich plasma or concentrated bone marrow aspirate. A Prospective Randomized Controlled Trial.
Secondary ID [1] 313224 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rotator cuff tear 335522 0
Condition category
Condition code
Musculoskeletal 332091 332091 0 0
Other muscular and skeletal disorders
Surgery 332231 332231 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arthroscopic rotator cuff repair with
1) leukocyte poor platelets rich plasma using Arthrex ACP® Double-Syringe System with approximately 50mL of blood aspirate or
2) concentrated bone marrow aspirate using Angel® cPRP and Bone Marrow Processing System using approximately 50mL of bone marrow aspirate or
3) COMPARATOR -nil augmentation.

The orthobiologic augmentation will be delivered via syringe directly to the footprint site of the rotator cuff repair and documented on the collection data sheet.

The rotator cuff repair will be performed by the consultant surgeon at registered site with approx 1hr duration. Records for each case will be recorded by the treating team to ensure adherence to the intervention.
Intervention code [1] 329798 0
Treatment: Surgery
Comparator / control treatment
Arthroscopic rotator cuff repair with nil augmentation
Control group
Active

Outcomes
Primary outcome [1] 339682 0
Constant-Murley Shoulder Outcome Score (CMS)
Timepoint [1] 339682 0
6mth at 1yr post operatively
Primary outcome [2] 339806 0
American Shoulder and Elbow Surgeons Score (ASES)
Timepoint [2] 339806 0
6mth at 1yr post operatively
Secondary outcome [1] 441104 0
3T MRI scan
Timepoint [1] 441104 0
Reviewed at 6mth and 1yr post operatively
Secondary outcome [2] 441429 0
Ultrasound
Timepoint [2] 441429 0
6mth at 1yr post operatively

Eligibility
Key inclusion criteria
- Patient aged between 18-75 undergoing primary arthroscopic rotator cuff repair (aRCR)
- Symptomatic rotator cuff tear confirmed on pre-op MRI (small to massive)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous rotator cuff surgery
- Glenohumeral joint arthritis
- Inflammatory arthropathy
- Instability
- History of platelet rich plasma injection, bone marrow aspirate injection or other biologic injections in the past 12 months
- Significant psychiatric disorder
- Cognitive impairment
- Current drug and alcohol abuse
- Active acute or chronic infection
- Inability to 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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After patient enrolment into the ORIQL Databank, the practice nurse will notify the ORIQL Research Coordinator, who will assign the patient to a study group based on a predetermined list of random numbers using a random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,TAS

Funding & Sponsors
Funding source category [1] 317666 0
Charities/Societies/Foundations
Name [1] 317666 0
The Orthopaedic Research Institute of Queensland Mater Hospital
Country [1] 317666 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Orthopaedic Research Institute of Queensland Mater Hospital
Address
Country
Australia
Secondary sponsor category [1] 319982 0
None
Name [1] 319982 0
Address [1] 319982 0
Country [1] 319982 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316366 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 316366 0
http://www.materresearch.org.au/about-us/human-research-ethics-and-governance/human-research-ethics
Ethics committee country [1] 316366 0
Australia
Date submitted for ethics approval [1] 316366 0
10/01/2025
Approval date [1] 316366 0
Ethics approval number [1] 316366 0

Summary
Brief summary
The objective of this study is to assess the tendon healing rates and clinical outcomes of arthroscopic rotator cuff repair (aRCR). This randomised control trial (RCT) will compare the standard aRCR (Control group) with two treatment groups, aRCR augmented with either intra-operative administration of concentrated bone marrow aspirate (cBMA) or leukocyte-poor platelet rich plasma (LP-PRP).

We hypothesise that augmented rotator cuff repair will result in statistically significant benefits for rotator cuff healing on ultrasound and MRI as well as clinical shoulder scores.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137662 0
Mrs Andrea Grant
Address 137662 0
The ORIQL, 7 Turner St, Pimlico QLD 4812
Country 137662 0
Australia
Phone 137662 0
+6174755 0564
Fax 137662 0
Email 137662 0
[email protected]
Contact person for public queries
Name 137663 0
Andrea Grant
Address 137663 0
The ORIQL, 7 Turner St, Pimlico QLD 4812
Country 137663 0
Australia
Phone 137663 0
+6174755 0564
Fax 137663 0
Email 137663 0
[email protected]
Contact person for scientific queries
Name 137664 0
Andrea Grant
Address 137664 0
The ORIQL, 7 Turner St, Pimlico QLD 4812
Country 137664 0
Australia
Phone 137664 0
+6174755 0564
Fax 137664 0
Email 137664 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.