Who is sponsoring NCT03730207?

NCT03730207 is sponsored by Medtronic Spinal and Biologics.

What drugs are being tested in NCT03730207?

Interventions in NCT03730207: Xpede™ Bone Cement, Mendec Spine Bone Cement.

What condition does NCT03730207 study?

NCT03730207 studies Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder), Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder).

Is NCT03730207 still recruiting?

NCT03730207 is currently completed. Last updated 10 January 2023.

Are results published for NCT03730207?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-01-10 · How we verify

NCT03730207

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Xpede Clinical Study

Completed NA Results posted Last updated 10 January 2023

What this trial tests

NA trial testing Xpede™ Bone Cement in Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder) in 180 participants. Completed in 14 October 2021.

Timeline

18 December 2018

Primary endpoint
14 October 2021

14 October 2021

Quick facts

Lead sponsor	Medtronic Spinal and Biologics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	180
Start date	18 December 2018
Primary completion	14 October 2021
Estimated completion	14 October 2021
Sites	3 locations across China

Drugs / interventions tested

Xpede™ Bone Cement
Mendec Spine Bone Cement

Conditions studied

Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder) — all drugs for Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder) →
Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder) — all drugs for Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder) →

Sponsor

Medtronic Spinal and Biologics — full company profile →

Who can join

Adults 18 to 80, any sex, with Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder) or Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative Primary · Baseline and 6 months

NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

Group	Value	95% CI
Xpede™ Bone Cement	-4.2	± 2.86
Mendec Spine Bone Cement	-4.4	± 2.76

The Change of Index Vertebral Body Angle From Baseline at 6 Months Primary · Baseline and 6 months

Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.

Group	Value	95% CI
Xpede™ Bone Cement	-0.869	-1.817 – 0.078
Mendec Spine Bone Cement	-0.952	-1.878 – -0.027

The Change of NRS Score From Baseline at 1 Day and 3 Months Secondary · Baseline, 1 day, and 3 months

NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

The change of NRS score from baseline at 1 day

Group	Value	95% CI
Xpede™ Bone Cement	-2.9	-3.5 – -2.3
Mendec Spine Bone Cement	-2.3	-2.9 – -1.7

The change of NRS score from baseline at 3 months

Group	Value	95% CI
Xpede™ Bone Cement	-3.6	-4.2 – -3.1
Mendec Spine Bone Cement	-3.8	-4.4 – -3.3

The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months Secondary · Baseline, 1 day, 3 months, and 6 months

ODI Questionnaire is used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

The change of ODI score from baseline 3 months

Group	Value	95% CI
Xpede™ Bone Cement	-26.407	-31.714 – -21.100
Mendec Spine Bone Cement	-29.108	-34.331 – -23.885

The change of ODI score from baseline 6 months

Group	Value	95% CI
Xpede™ Bone Cement	-26.407	-31.714 – -21.100
Mendec Spine Bone Cement	-29.108	-34.331 – -23.885

The change of ODI score from baseline 1 day

Group	Value	95% CI
Xpede™ Bone Cement	-1.757	-7.297 – 3.782
Mendec Spine Bone Cement	1.746	-3.698 – 7.190

The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months Secondary · Baseline, 1 day, 3 months, and 6 months

The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) is used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS/MCS is between 0 and 100, with higher scores denoting better quality of life.

The change of SF-36(MCS)from baseline at 6 months

Group	Value	95% CI
Xpede™ Bone Cement	3.781	-0.106 – 7.668
Mendec Spine Bone Cement	-1.436	-5.190 – 2.317

The change of SF-36(MCS) from baseline at 3 months

Group	Value	95% CI
Xpede™ Bone Cement	5.740	2.018 – 9.462
Mendec Spine Bone Cement	0.086	-3.498 – 3.671

The change of SF-36(MCS)from baseline at 1 day

Group	Value	95% CI
Xpede™ Bone Cement	0.650	-2.591 – 3.890
Mendec Spine Bone Cement	0.809	-2.293 – 3.911

The change of SF-36(PCS)from baseline at 6 months

Group	Value	95% CI
Xpede™ Bone Cement	7.855	4.838 – 10.872
Mendec Spine Bone Cement	9.683	6.725 – 12.641

The change of SF-36(PCS)from baseline at 3 months

Group	Value	95% CI
Xpede™ Bone Cement	5.740	2.783 – 8.697
Mendec Spine Bone Cement	6.504	3.605 – 9.404

The change of SF-36(PCS)from baseline at 1 day

Group	Value	95% CI
Xpede™ Bone Cement	-3.104	-5.596 – -0.611
Mendec Spine Bone Cement	-3.654	-6.097 – -1.211

Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months Secondary · 1 day, 3 months, and 6 months

Vertebral Body Height in the lateral projection will be measured at each treated vertebra as well as the next adjacent vertebrae (superior and inferior) without fracture and reported in millimeters. Vertebral Body Height is the distance between comparable points on the superior and inferior endplates of the vertebral body at the posterior (Hp), midline (Hm) and anterior (Ha) locations。

Change in vertebral body height (Anterior height) restoration at 6 months

Group	Value	95% CI
Xpede™ Bone Cement	-4.271	-5.348 – -3.195
Mendec Spine Bone Cement	-4.429	-5.492 – -3.366

Change in vertebral body height (Anterior height) restoration at 3 months

Group	Value	95% CI
Xpede™ Bone Cement	-3.949	-5.040 – -2.859
Mendec Spine Bone Cement	-4.154	-5.234 – -3.074

Change in vertebral body height (Anterior height) restoration at 1 day

Group	Value	95% CI
Xpede™ Bone Cement	-2.514	-3.597 – -1.432
Mendec Spine Bone Cement	-2.738	-3.809 – -1.666

Change in vertebral body height (Mid-vertebral height) restoration at 1 day

Group	Value	95% CI
Xpede™ Bone Cement	-2.375	-2.375 – -1.531
Mendec Spine Bone Cement	-2.845	-3.679 – -2.011

Change in vertebral body height (Mid-vertebral height) restoration at 3 months

Group	Value	95% CI
Xpede™ Bone Cement	-3.727	-4.610 – -2.844
Mendec Spine Bone Cement	-3.979	-4.850 – -3.108

Change in vertebral body height (Mid-vertebral height) restoration at 6 months

Group	Value	95% CI
Xpede™ Bone Cement	-3.426	-4.255 – -2.597
Mendec Spine Bone Cement	-3.603	-4.418 – -2.788

Change in vertebral body height (Posterior height) restoration at 1 day

Group	Value	95% CI
Xpede™ Bone Cement	-0.128	-0.912 – 0.656
Mendec Spine Bone Cement	-0.613	-1.387 – 0.160

Change in vertebral body height (Posterior height) restoration at 3 months

Group	Value	95% CI
Xpede™ Bone Cement	-0.821	-1.682 – 0.041
Mendec Spine Bone Cement	-1.579	-2.426 – -0.732

Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months Secondary · Baseline, 1 day and 3 months

Change in Vertebral body angle from baseline at 3 months

Group	Value	95% CI
Xpede™ Bone Cement	-1.710	-2.693 – -0.727
Mendec Spine Bone Cement	-1.662	-2.629 – -0.695

Change in Vertebral body angle from baseline at 1 day

Group	Value	95% CI
Xpede™ Bone Cement	-2.739	-3.629 – -1.848
Mendec Spine Bone Cement	-2.375	-3.254 – -1.496

Number of Participants With Adverse Events Reported Through 6 Months Secondary · 6 months

Adverse events reported through 6 months, in particular, the following events will be reported: * Bone Cement Implantation Syndrome; * Bone Cement leakage; * Vertebral body compression fracture; * Adjacent vertebral body fracture;

Group	Value	95% CI
Xpede™ Bone Cement	28
Mendec Spine Bone Cement	32

Adverse events — posted to ClinicalTrials.gov

Time frame: The mean (±sd) total duration of study exposure was 196.3±49.49 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Xpede™ Bone Cement

Serious: 1/89 (1%)

Deaths: 2/89

Mendec Spine Bone Cement

Serious: 1/91 (1%)

Deaths: 1/91

Serious adverse events (3 terms)

Reaction	System	Xpede™ Bone Cement	Mendec Spine Bone Cement
Multiple organ failure	General disorders	—	—
Post-operative recurrence of right breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Xpede™ Bone Cement	Mendec Spine Bone Cement
Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Multiple organ failure, Post-operative recurrence of right breast cancer, Multiple myeloma.

Data from ClinicalTrials.gov NCT03730207 adverse events section.

Sponsor's own description

The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Medtronic Spinal and Biologics trials

Trials by the same sponsor.

NCT07414745 — MDT-0123 Japan Study · NA · not yet recruiting
NCT05299762 — A Post Market Surveillance on INFUSE Bone Graft · recruiting
NCT04929678 — Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis · NA · terminated
NCT03775694 — Diffusion MRI-1 Imaging Database · completed
NCT03797144 — Fenestrated Screw Study · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03730207 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medtronic Spinal and Biologics
Last refreshed: 10 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03730207.

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