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

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Recruiting

CT.gov ID

NCT05817747

Collaborator

(none)

900

Enrollment

Locations

Arms

Anticipated Duration (Months)

112.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Constriction, Pathologic Spine Degeneration Surgery Radiculopathy	Other: Dialogue support tool	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

On all participants the dialogue support tool will be used and will thereafter be put into either of two treatment-arms (surgical, or non-surgical treatment)On all participants the dialogue support tool will be used and will thereafter be put into either of two treatment-arms (surgical, or non-surgical treatment)

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

Mar 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgery Participants will after the dialogue support tool has been undergo surgery.	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.
Placebo Comparator: Non-surgery Participants will after the dialogue support tool has been used not undergo surgery.	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.

Arm

Intervention/Treatment

Experimental: Surgery

Participants will after the dialogue support tool has been undergo surgery.

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.

Placebo Comparator: Non-surgery

Participants will after the dialogue support tool has been used not undergo surgery.

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.

Outcome Measures

Primary Outcome Measures

Global Assessment (GA) [One year post surgery]
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).

Secondary Outcome Measures

Oswestry Disability Index (ODI) [One year post surgery]
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).
Neck Disability index (NDI) [One year post surgery]
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
Euroqol-5-Dimensions quality of life questionnaire (EQ-5D) [One year post surgery]
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).
Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS) [One year post surgery]
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
Mortality [One year post surgery]
The number of participants that have died within one year of surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aleris Ortopedi Malmö	Malmö	Skåne	Sweden	21532
2	Aleris Ortopedi Ängelholm	Ängelholm	Skåne	Sweden	26252
3	Sahlgrenska University Hospital	Gothenburg	Västra Götaland	Sweden	41346
4	Spine Center Göteborg	Göteborg	Västra Götaland	Sweden	421 30
5	Ryggkirurgiskt Centrum	Stockholm		Sweden	114 33
6	Spine Center Stockholm	Stockholm		Sweden	194 89
7	Uppsala University Hospital	Uppsala		Sweden	751 85
8	Aleris Elisabethsjukhuset	Uppsala		Sweden	752 26