Trial Outcomes & Findings for Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant (NCT NCT05337696)

Results Overview

Safety will be measured by number of device related serious adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

6 months

Results posted on

2026-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	Participants With Vertebral Compression Fractures Participants with vertebral compression fractures who have failed conservative care strategies. Vertebral Implant PEEK Procedure: Vertebral Implant PEEK (VIP) procedure is a minimally invasive/percutaneous vertebral augmentation (PVA), image guided procedure. Two VIP devices are implanted in each to be treated vertebra. A cavity is drilled allowing the introduction of the implant posteriorly through the pedicle and the vertebral body upto the anterior wall. A part of the implant is embedded into the pedicle, thus providing posterior support. The other part of the device, located in the vertebral body, presents a central canula and lateral perforations, which allow acrylic bone cement diffusion, filling of the vertebral body, filling and fixing the implant, and supporting of the upper endplate. The combination of the implant and the cement allows the treatment of vertebral fractures. Vertebral Implant PEEK (VIP) implant: The study device is V-STRUT© Vertebral Implant manufactured by Hyprevention (VIP -Vertebral Implant PEEK), FDA cleared under K191709, indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with PMMA bone cement.
Overall Study STARTED	23
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With Vertebral Compression Fractures Participants with vertebral compression fractures who have failed conservative care strategies. Vertebral Implant PEEK Procedure: Vertebral Implant PEEK (VIP) procedure is a minimally invasive/percutaneous vertebral augmentation (PVA), image guided procedure. Two VIP devices are implanted in each to be treated vertebra. A cavity is drilled allowing the introduction of the implant posteriorly through the pedicle and the vertebral body upto the anterior wall. A part of the implant is embedded into the pedicle, thus providing posterior support. The other part of the device, located in the vertebral body, presents a central canula and lateral perforations, which allow acrylic bone cement diffusion, filling of the vertebral body, filling and fixing the implant, and supporting of the upper endplate. The combination of the implant and the cement allows the treatment of vertebral fractures. Vertebral Implant PEEK (VIP) implant: The study device is V-STRUT© Vertebral Implant manufactured by Hyprevention (VIP -Vertebral Implant PEEK), FDA cleared under K191709, indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with PMMA bone cement.
Overall Study Death	1
Overall Study Lost to Follow-up	3
Overall Study Physician Decision	1
Overall Study Trial Closure	8
Overall Study Screen Failure	2

Baseline Characteristics

Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Vertebral Compression Fractures n=21 Participants Participants with vertebral compression fractures who have failed conservative care strategies. Vertebral Implant PEEK Procedure: Vertebral Implant PEEK (VIP) procedure is a minimally invasive/percutaneous vertebral augmentation (PVA), image guided procedure. Two VIP devices are implanted in each to be treated vertebra. A cavity is drilled allowing the introduction of the implant posteriorly through the pedicle and the vertebral body upto the anterior wall. A part of the implant is embedded into the pedicle, thus providing posterior support. The other part of the device, located in the vertebral body, presents a central canula and lateral perforations, which allow acrylic bone cement diffusion, filling of the vertebral body, filling and fixing the implant, and supporting of the upper endplate. The combination of the implant and the cement allows the treatment of vertebral fractures. Vertebral Implant PEEK (VIP) implant: The study device is V-STRUT© Vertebral Implant manufactured by Hyprevention (VIP -Vertebral Implant PEEK), FDA cleared under K191709, indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with PMMA bone cement.
Age, Continuous	73.95 years STANDARD_DEVIATION 11.61 • n=51 Participants
Sex: Female, Male Female	15 Participants n=51 Participants
Sex: Female, Male Male	6 Participants n=51 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=51 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=51 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=51 Participants
Race (NIH/OMB) Asian	3 Participants n=51 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=51 Participants
Race (NIH/OMB) Black or African American	1 Participants n=51 Participants
Race (NIH/OMB) White	15 Participants n=51 Participants
Race (NIH/OMB) More than one race	0 Participants n=51 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=51 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Study terminated early.

Safety will be measured by number of device related serious adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0