COMPlex REconStructive Surgery Outcomes Registry (CompResSOR): a clinical outcomes registry for patients undergoing complex orthopaedic reconstructive surgery.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12621001421820

Acronym

COMPRESSOR

Enrollment

218

Registered

2021-10-21

Start date

2022-02-25

Completion date

2032-10-01

Last updated

2023-12-12

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

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

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

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

Outcome results