Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.

NCT06141187 | Recruiting DMC

• 1 other identifier: MS/KIR 012/2023
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications associated with performing vertebroplasty. The primary outcome is improvement of pain intensity as measured on a Visual Analog Scale (VAS, 0 to100) 12 weeks after treatment. Secondary outcomes include patient-reported back-related disability, patient-reported quality of life, spinal sagittal balance, complications associated with the procedure, incidence of new OVCFs and socioeconomic costs.

Conditions

Osteoporotic Fractures; Vertebral Fracture

Keywords

vertebroplasty; Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity using the 100-point VAS

  Self-reported average pain intensity over the previous 24 hours, using the 100-point VAS will be recorded at time of randomization and after 1, 2, 3, 4 and 5 days, and after 2, 4, 8 and 12 weeks, and finally at 12 months and 24 months post-randomization

  VAS will be recorded at time of randomization and after 1, 2, 3, 4 and 5 days, and after 2, 4, 8 and 12 weeks, and finally at 12 months and 24 months post-randomization

Secondary Outcomes (5)

• Patient-reported disability.

  Recorded at enrolment and at 4 and 12 weeks, 12 and 24 months post-randomization

• Health-related quality of life.

  Recorded at enrolment and at 4 and 12 weeks, 12 and 24 months post-randomization

• Global Perceived Effect scale

  Recorded at 4 and 12 weeks, 12 and 24 months post-randomization

• Sagittal balance

  Recorded at enrolment and 12 months post-randomization

• Societal costs of treatment

  Recorded 1 day at discharge and 12 months post-randomization

Study Arms (2)

Vertebroplasty

ACTIVE COMPARATOR

Polymethyl-methacrylate (PMMA) cement is prepared and injected slowly into the vertebral body under constant bi-plane fluoroscopy

Procedure: Vertebroplasty

Sham vertebroplasty

SHAM COMPARATOR

A short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body.

Procedure: Sham Vertebroplasty

Interventions

Vertebroplasty PROCEDURE

PVP

Vertebroplasty

Sham Vertebroplasty PROCEDURE

Sham PVP

Sham vertebroplasty

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl).
• Focal tenderness on the level of the vertebral fracture.
• Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence
• Osteoporotic Fractures type 1-4.
• Fracture involves no more than 4 vertebral body levels.
• PVP can be done in one session.
• Back pain score measured on a Visual Analog Scale (VAS, 0 to 100) ≥ 60.
• Able to understand and read Danish.
• Written informed consent.
• Relevant pain started ≤ 3 months prior to enrollment.

You may not qualify if:

• \- Contra-indications for spine surgery.
• Platelets \< 30 mia/l.
• Osteoporotic Fractures type 5 and Pincer-type.
• Complete collapse of the vertebral body precluding insertion of needle.
• Presence of neurologic deficit.
• Contraindications for MRI scanning.
• Psychological or psychiatric disorder that is expected to interfere with compliance.
• Active malignancy.
• Mini Mental State Examination (MMSE) test score below 24.
• History of chronic back pain requiring ongoing opiate use.
• Systemic or local infection of the spine.

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead

Study Sites (1)

Rygcenter Syddanmark

Middelfart, Fyn, 5500, Denmark

RECRUITING

Related Publications (1)

• Andersen MO, Andresen AK, Hartvigsen J, Hermann AP, Sorensen J, Carreon LY. Vertebroplasty for painful osteoporotic vertebral compression fractures: a protocol for a single-center doubled-blind randomized sham-controlled clinical trial. VOPE2. J Orthop Surg Res. 2024 Nov 30;19(1):813. doi: 10.1186/s13018-024-05301-x.

  PMID: 39614265 DERIVED

MeSH Terms

Conditions

Osteoporotic Fractures; Spinal Fractures; Pain

Interventions

Vertebroplasty

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Spinal Injuries; Back Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Mikkel Ø Andersen, MD

  Sygehus Lillebælt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikkel Ø Andersen, MD

CONTACT

+45 2320 9173; mikkel.andersen2@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 6, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)