Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture

NCT06776003 | Recruiting

• 2 other identifiers: 23/40938112199
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to determine if vertebroplasty is an effective treatment for acute, painful vertebral fractures due to osteoporosis. The focus of the study is on the physical activity and mobility of participants. The main questions the trial aims to answer are:

• Does vertebroplasty lead to increased physical activity as measured by accelerometer?
• Does vertebroplasty lead to increased mobility as measured by GPS (global positioning system)?
• Do physical activity and mobility correlate with pain, disability and quality of life? Researchers will compare vertebroplasty to sham (simulated surgery without active intervention) to understand if vertebroplasty improves physical activity and mobility. Participants will
• Undergo vertebroplasty or sham procedure
• Wear an accelerometer and a GPS-reciever in a belt for 1 week before to 4 weeks after the surgery
• Answer questionnaires regarding pain, disability and quality of life at regular intervals. The knowledge gained from this can help determine who would benefit from vertebroplasty.

Conditions

Osteoporotic Vertebral Compression Fractures

Keywords

Accelerometer; Global Positioning System; Vertebroplasty; Physical Activity; Mobility; Osteoporosis; Spinal Surgery; ActiGraph; Accelerometry; GPS; Osteoporotic

Outcome Measures

Primary Outcomes (1)

• Change in physical activity before and after intervention

  Physical activity is measured by accelerometer and presented as mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day). An unweighted average of valid days within the preoperative week is compared with the unweighted average of valid days within the four postoperative weeks by relative change in percent.

  One week preoperatively to the end of the fourth postoperative week.

Secondary Outcomes (10)

• Daily and weekly physical activity

  One week preoperatively to 4 weeks postoperatively

• Change in daily and weekly physical activity

  One week preoperatively to 4 weeks postoperatively

• Physical activity levels

  One week preoperatively to 4 weeks postoperatively

• Change in physical activity levels

  One week preoperatively to 4 weeks postoperatively

• Total daily distance and change in total daily distance

  One week preoperatively to 4 weeks postoperatively

Study Arms (2)

Vertebroplasty

ACTIVE COMPARATOR

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

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. Interventions: Procedure: Sham Vertebroplasty

Procedure: Sham Vertebroplasty

Interventions

Vertebroplasty PROCEDURE

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

Also known as: Percutaneous vertebroplasty, PVP

Vertebroplasty

Sham Vertebroplasty PROCEDURE

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.

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.
• Vertebroplasty 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)

Spine Centre of Southern Denmark

Kolding, 6000, Denmark

RECRUITING

MeSH Terms

Conditions

Motor Activity; Osteoporosis

Interventions

Vertebroplasty

Condition Hierarchy (Ancestors)

Behavior; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Mikkel Ø Andersen, Prof, MD

  Spine Centre of Southern Denmark

  STUDY CHAIR

Central Study Contacts

Søren W Sørensen, MD

CONTACT

0045 76362000; soren.wittorff.sorensen@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: January 9, 2025
• First Posted: January 15, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The IPD and data will be stored for five years from the completetion of the study at the trial site followed by archiving at the Danish National Archives.
• Access Criteria: Researchers can request access to the information by contacting the investigator via email at soren.wittorff.sorensen@rsyd.dk

Locations

DK (1)