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

NCT05817747 | Recruiting

• 1 other identifier: 2022-2025
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 10

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.

Conditions

Constriction, Pathologic; Spine Degeneration; Surgery; Radiculopathy

Keywords

Spine; Cervical radiculopathy; Lumbar spinal stenosis; Surgery; Neck; Prognostic model; External validation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Oswestry Disability Index (ODI)

  One year post surgery

• Neck Disability index (NDI)

  One year post surgery

• Euroqol-5-Dimensions quality of life questionnaire (EQ-5D)

  One year post surgery

• Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS)

  One year post surgery

• Mortality

  One year post surgery

Study Arms (2)

Surgery

EXPERIMENTAL

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

Other: Dialogue support tool

Non-surgery

PLACEBO COMPARATOR

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

Other: Dialogue support tool

Interventions

Dialogue support tool OTHER

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.

Non-surgery; Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Another condition found to be the reason for the symptoms.
• Not giving informed consent

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (10)

Aleris Ortopedi Ängelholm

Ängelholm, Skåne County, 26252, Sweden

RECRUITING

Aleris Ortopedi Malmö

Malmo, Skåne County, 21532, Sweden

ACTIVE NOT RECRUITING

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41346, Sweden

RECRUITING

Spine Center Göteborg

Gothenburg, Västra Götaland County, 421 30, Sweden

RECRUITING

Ryggkirurgiskt Centrum

Stockholm, 114 33, Sweden

RECRUITING

Spine Center Stockholm

Stockholm, 194 89, Sweden

RECRUITING

Sundsvalls sjukhus

Sundsvall, Sweden

RECRUITING

Norrland University Hospital

Umeå, 90737, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, 751 85, Sweden

RECRUITING

Aleris Elisabethsjukhuset

Uppsala, 752 26, Sweden

ACTIVE NOT RECRUITING

Related Publications (1)

• Enger EB, Valentin-Askman L, Hagg O, Fritzell P, Parai C. The strategic use of Big Data - A study protocol for a multicenter clinical trial testing if the use of the Swespine Dialogue Support alter outcomes in degenerative spine surgery. BMC Musculoskelet Disord. 2024 Aug 21;25(1):654. doi: 10.1186/s12891-024-07714-5.

  PMID: 39169349 DERIVED

MeSH Terms

Conditions

Constriction, Pathologic; Radiculopathy; Spinal Stenosis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Catharina Parai, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catharina Parai, MD, PhD

CONTACT

0046313421000; catharina.parai@vgregion.se

Eric Brisby Enger, MD

CONTACT

0046735716723; ericbrisbyenger@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: April 18, 2023
• Study Start: March 1, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

SE (10)