Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis

Surgery Clinical Trial

Official title:

Strategic Use of Big Data in Spine Surgery - Testing a Digital Prediction of Outcome Tool in Clinical Praxis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817747
• Other study ID #: 2022-2025
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 1, 2029

Study information

• Verified date: April 2024
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Catharina Parai, MD, PhD
• Phone: 0046313421000
• Email: catharina.parai[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this prospective, multicenter clinical trial is to determine if the use of the postoperative outcome prediction model the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction compared to current practice.

The main questions it aims to answer are:

• Does its use alter patient-reported outcome measured by general assessment regarding leg pain and Satisfaction in lumbar spinal stenosis?

• Does its use alter patient-reported outcome as measured by general assessment regarding arm pain and Satisfaction in cervical rhizopathy?

• How does the Quality of Life in patients - who after assessment by spinal surgeon do not proceed to surgery - compare with patients with the same baseline profile who did undergo surgery?

Eligible participants will be presented with their predicted postoperative outcome generated by the Dialogue Support tool, as an adjunct to the ordinary assessment by a spine surgeon.

Researchers will compare participants with a matched control group from the Swedish Spine Register ("Swespine") to see if the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: March 1, 2029
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Refered to a participating clinic regarding surgery for lumbar spinal stenosis or cervical radiculopathy

• 18 years of age or older

• Magnetic Resonance Imaging (MRT) examination within the last 12 months confirming the diagnosis, concurrent with symptoms described by the referring physician

• Giving informed consent

Exclusion Criteria:

• Another condition found to be the reason for the symptoms.

• Not giving informed consent

• Need for further investigation that prevents inclusion within one month of the doctor visit.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Radiculopathy
• Spine Degeneration
• Surgery

Intervention

Other:
• Dialogue support tool
The dialogue support tool will be used as a support for the participant and surgeon to decide on which treatment arm is optimal for the participant.

Locations

Country	Name	City	State
Sweden	Aleris Ortopedi Ängelholm	Ängelholm	Skåne
Sweden	Spine Center Göteborg	Göteborg	Västra Götaland
Sweden	Sahlgrenska University Hospital	Gothenburg	Västra Götaland
Sweden	Aleris Ortopedi Malmö	Malmö	Skåne
Sweden	Ryggkirurgiskt Centrum	Stockholm
Sweden	Spine Center Stockholm	Stockholm
Sweden	Norrland University Hospital	Umeå
Sweden	Aleris Elisabethsjukhuset	Uppsala
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Assessment (GA)	A retrospective single-item question ("How is your back/leg or neck/arm pain today as compared to before the surgery?"), with six response options (not back/leg pain before surgery/completely gone/much improved/slightly improved/unchanged/worse).	One year post surgery
Secondary	Oswestry Disability Index (ODI)	assesses the impact of lumbar pain on a patient´ physical function. It consists of ten questions concerning intensity of pain, ability to care for oneself, lifting, ability to walk, ability to sit, ability to walk, sexual function, social life, sleep quality and ability to travel. Min. value 0 points (no disability) and max. value 50 points (completely disabled).	One year post surgery
Secondary	Neck Disability index (NDI)	Used to assess the self-rated disability in patients with neck pain and consisting of ten questions scaled from 0-5 concerning pain-intensity, ability to care for oneself, lifting, reading, headache, concentration, working, driving, sleep and recreational activity	One year post surgery
Secondary	Euroqol-5-Dimensions quality of life questionnaire (EQ-5D)	Assess quality of life. It describes health in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression).	One year post surgery
Secondary	Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS)	The NRS is a common way of grading pain experience and is presented to the patient as a line with numbers from 0-10 and the patient is asked to grade their pain experience where zero is no pain and ten is maximal pain	One year post surgery
Secondary	Mortality	The number of participants that have died within one year of surgery	One year post surgery