Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001421820
Ethics application status
Approved
Date submitted
19/05/2021
Date registered
21/10/2021
Date last updated
1/12/2023
Date data sharing statement initially provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
COMPlex REconStructive Surgery Outcomes Registry (CompResSOR): a clinical outcomes registry for patients undergoing complex orthopaedic reconstructive surgery.
Scientific title
COMPlex REconStructive Surgery Outcomes Registry (CompResSOR): a clinical outcomes registry for patients undergoing complex orthopaedic reconstructive surgery.
Secondary ID [1] 303544 0
None
Universal Trial Number (UTN)
U1111-1265-3257
Trial acronym
COMPRESSOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone and soft tissue tumours of the upper limb 321971 0
Bone and soft tissue tumours of the pelvis 321972 0
Revision hip arthroplasty 321973 0
Bone and soft tissue tumours of the lower limb 328518 0
Revision knee arthroplasty 328519 0
Condition category
Condition code
Cancer 319694 319694 0 0
Bone
Musculoskeletal 319695 319695 0 0
Other muscular and skeletal disorders
Surgery 319696 319696 0 0
Surgical techniques
Cancer 319697 319697 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Participants will be undergoing multidisciplinary management of bone and soft tissue tumours, or surgery to revise a failed or infected hip replacement.

Multidisciplinary management of bone and soft tissue tumours may include surgical resection with or without reconstruction using prostheses or bone/tissue grafts, neoadjuvant or adjuvant chemotherapy if indicated, radiation therapy, and postoperative physical rehabilitation.

Hip arthroplasty revisions will be performed with indicated surgical techniques, hardware, grafts, debridement and antibiotic therapy if indicated, and postoperative physical rehabilitation.

For the registry, participants will agree to the transfer of routinely captured clinical information from their surgeon's records to the registry database. This includes demographic information, medical history, results of testing, and details of any procedures performed for management of the participant's condition.

Participants will also be asked to complete questionnaires to assist with clinical monitoring. For the purposes of the registry, these will be administered electronically at baseline, and again at 3 months, 6 months, 12 months, 24 months, and 5 years after definitive treatment. Participants will be able to complete the questionnaires (a maximum of 6 at one time) at home on their preferred device, or in clinic during routine clinical followup visits. The questionnaires are expected to take no more than twenty minutes to complete at each followup.
Intervention code [1] 320593 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327577 0
All cohorts - Disease-associated quality of life, measured via the Veterans RAND-12 (VR-12) quality of life questionnaire.
Timepoint [1] 327577 0
Preoperative, and 3 months, 6 months, 12 months, 24 months, 5 years following definitive treatment (surgical or otherwise).
Secondary outcome [1] 395709 0
Tumour cohorts, and revision knee arthroplasty cohort - Patient-reported limb function, as measured by a modified (patient-reported) version of the Musculoskeletal Society Tumour Score (MSTS; Enneking et al., 1993).
Timepoint [1] 395709 0
3 months, 6 months, 12 months, 24 months, 5 years following definitive treatment (surgical or otherwise).
Secondary outcome [2] 395710 0
Upper limb cohort - Upper limb function as measured by the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH).
Timepoint [2] 395710 0
pre-treatment, and 3 months, 6 months, 12 months, 24 months, 5 years following definitive treatment (surgical or otherwise).
Secondary outcome [3] 395711 0
Hip function as measured by the Hip disability and Osteoarthritis Outcome Score (HOOS-12). This outcome will be measured in the pelvic tumour and revision hip arthroplasty cohorts.
Timepoint [3] 395711 0
pre-treatment, and 3 months, 6 months, 12 months, 24 months, 5 years following definitive treatment (surgical or otherwise).
Secondary outcome [4] 395712 0
Tumour cohorts - Patient-reported pain as measured with the Brief Pain Inventory (BPI).
Timepoint [4] 395712 0
3 months, 6 months, 12 months, 24 months, 5 years following definitive treatment (surgical or otherwise).
Secondary outcome [5] 395713 0
Tumour cohorts - Patient-reported sleep quality - the Pittsburgh Sleep Quality Index.
Timepoint [5] 395713 0
3 months, 6 months, 12 months, 24 months, 5 years following definitive treatment (surgical or otherwise).
Secondary outcome [6] 395714 0
All cohorts - Patient survival - determined through linkage with practice records.
Timepoint [6] 395714 0
3 months, 6 months, 12 months, 24 months, 5 years following definitive treatment (surgical or otherwise).
Secondary outcome [7] 395715 0
Revision hip arthroplasty cohort - Patient-reported satisfaction with symptoms, measured with the MODEMs satisfaction questionnnaire.
Timepoint [7] 395715 0
12 months, 24 months, 5 years following revision hip arthroplasty.
Secondary outcome [8] 395716 0
All cohorts - Incidence of complications, such as periprosthetic fracture, hardware failure, infection, etc. as determined by linkage to practice records.
Timepoint [8] 395716 0
3 months, 6 months, 12 months, 24 months, 5 years following definitive treatment (surgical or otherwise).
Secondary outcome [9] 400693 0
Tumour cohorts - Resection margins, determined by surgeon and/or pathologist reports.
Timepoint [9] 400693 0
3 months following surgical treatment
Secondary outcome [10] 400694 0
All cohorts - Component placement/orientation relative to planned placement (degrees/mm deviation from preoperative plan) as determined from imaging reports.
Timepoint [10] 400694 0
3 months following surgical treatment.
Secondary outcome [11] 400695 0
All cohorts - Repeat or additional interventions (composite outcome incorporating Incidence and Reason for intervention, for example hardware failure, disease recurrence or progression, periprosthetic fracture etc,). Determined by linkage to practice records.
Timepoint [11] 400695 0
3 months, 6 months, 12 months, 24 months, 5 years following definitive treatment (surgical or otherwise).
Secondary outcome [12] 416862 0
Revision knee arthroplasty cohort - Central sensitisation (Increased responsiveness of pain receptors as a response to prolonged injury or pathology) as measured with the Central Sensitisation Inventory
Timepoint [12] 416862 0
At baseline
Secondary outcome [13] 416863 0
Revision knee arthroplasty cohort - Knee function as measured via the 12-item version of the Knee Osteoarthritis Outcome Score (KOOS-12).
Timepoint [13] 416863 0
Baseline, and at 3 months, 6 months, 12 months, 24 months, and 5 years following definitive treatment.
Secondary outcome [14] 416864 0
Lower limb tumour cohort - Physical activity, as measured by a self-administered version of the Global Physical Activity Questionnaire.
Timepoint [14] 416864 0
Baseline, and 3 months, 6 months, 12 months, 2 years, 5 years following definitive intervention.

Eligibility
Key inclusion criteria
Presenting to the participating surgeon(s) for management of pathologies covered under one of the active cohorts;
Aged 16 years or over on date of initial examination;
Capable of providing informed consent
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sign and return opt-out form;
(PROMs) Unable to comprehend or communicate responses to standardised questions on forms provided electronically
(PROMs) Request to be excluded from questionnaires

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Due to the anticipated limited sample size, the initial analyses of Registry data will comprise annual reporting of summary statistics and pre-postoperative change in outcomes scores at each followup. As the registry increases in size, analyses will incorporate binary logistic regression modelling to identify factors independently predictive of later outcomes at approximately 2 years post treatment. A detailed outline of planned statistical analysis for each cohort can be obtained from the Principal Investigator on request.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2022
Actual
25/02/2022
Date of last participant enrolment
Anticipated
1/10/2032
Actual
Date of last data collection
Anticipated
1/10/2037
Actual
Sample size
Target
500
Accrual to date
218
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 34063 0
2042 - Newtown
Recruitment postcode(s) [2] 34064 0
2088 - Mosman
Recruitment postcode(s) [3] 34065 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 307968 0
Commercial sector/Industry
Name [1] 307968 0
OSSIS Ltd.
Country [1] 307968 0
New Zealand
Primary sponsor type
Individual
Name
Dr Richard Boyle
Address
RPAH Medical Centre , 100 Carillon Ave, Newtown NSW 2042
Country
Australia
Secondary sponsor category [1] 309506 0
None
Name [1] 309506 0
Address [1] 309506 0
Country [1] 309506 0
Other collaborator category [1] 281786 0
Commercial sector/Industry
Name [1] 281786 0
EBM Analytics
Address [1] 281786 0
119 Willoughby Road, Crows Nest NSW 2067, Australia
Country [1] 281786 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307962 0
Sydney Local Health District (RPA Zone) HREC
Ethics committee address [1] 307962 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Sydney Local Health District
Level 11, KGV Building Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 307962 0
Australia
Date submitted for ethics approval [1] 307962 0
06/04/2021
Approval date [1] 307962 0
02/09/2021
Ethics approval number [1] 307962 0
2021/ETH00634

Summary
Brief summary
This study aims to collect clinical outcomes data, particularly quality of life and limb function outcomes, from patients who have undergone either a surgical procedure to remove/treat bone and soft tissue tumours (cancer patients) or patients who have undergone a complex hip reconstruction surgery (non-cancer patients) to determine how these outcomes relate to surgical factors.

Who is it for?
You may be eligible for this study if you are aged 16 or older, and you are attending for consultation with one of the participating surgeons for management (surgery with or without chemotherapy or radiotherapy) of bone and soft tissue (sarcoma) tumours, or for surgery to revise a failed or infected hip replacement (non-cancer patients).

Study details
All participants who choose to enrol in this study will be asked to complete a series of questionnaires around the time of their first consultation with the surgeon, and again at 3, 6, 12, 24 and 60 months (5 years) following definitive treatment (whether treatment is surgical or otherwise). Participants will be able to complete these questionnaires in their own time via an online link, or can complete them at their regular follow up clinic visits. It is anticipated that completing all of the questionnaires at each timepoint will take around 20 minutes.

It is hoped this research will provide surgeons with information which will be used to improve the precision of patient counselling preoperatively, and to tailor treatment decisions and post-operative management in order to maximise patient quality of life. The data will also be analysed together and results shared with the scientific community, to help patients in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109058 0
Dr Richard Boyle
Address 109058 0
RPAH Medical Centre
Suite 101
100 Carillon Avenue
Newtown NSW 2042
Country 109058 0
Australia
Phone 109058 0
+61280640310
Fax 109058 0
Email 109058 0
[email protected]
Contact person for public queries
Name 109059 0
Dr Richard Boyle
Address 109059 0
RPAH Medical Centre
Suite 101
100 Carillon Avenue
Newtown NSW 2042
Country 109059 0
Australia
Phone 109059 0
+61280640310
Fax 109059 0
Email 109059 0
[email protected]
Contact person for scientific queries
Name 109060 0
Dr Richard Boyle
Address 109060 0
RPAH Medical Centre
Suite 101
100 Carillon Avenue
Newtown NSW 2042
Country 109060 0
Australia
Phone 109060 0
+61280640310
Fax 109060 0
Email 109060 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant-level data or aggregate outcomes data
When will data be available (start and end dates)?
Beginning 2 years from study start date. No end date.
Available to whom?
De-identified participant-level data may be shared with investigators following approval by the reviewing HREC.
Available for what types of analyses?
Research projects approved by an NHMRC-certified HREC.
How or where can data be obtained?
Contact the Principal Investigator at [email protected] for more information.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11712Study protocol    Available from the PI on request
11713Statistical analysis plan    Available from the PI on request
13672Ethical approval    Available from the PI on request



Results publications and other study-related documents

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