Calcium Sulfate Spacer in Open Tibia Fractures

NCT03042546 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: STUDY00002348
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.

Conditions

Open tíbia Fracture With Sub-segmental Bone Loss

Outcome Measures

Primary Outcomes (1)

• Number of Patients With a Nonunion

  Radiographic healing at one year with no additional surgery

  One Year

Study Arms (3)

Calcium Sulphate

ACTIVE COMPARATOR

Drug: Calcium Sulfate

PMMA

ACTIVE COMPARATOR

Drug: PMMA

Nothing

ACTIVE COMPARATOR

Other: No treatment

Interventions

Calcium Sulfate DRUG

Calcium Sulfate with abx will be used in the defect

Calcium Sulphate

PMMA DRUG

PMMA with abx will be used in the defect

PMMA

No treatment OTHER

The defect will not be treated

Nothing

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Open tibia shaft fracture treated with an IMN

You may not qualify if:

• None

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

Calcium Sulfate; Polymethyl Methacrylate

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Minerals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Methylmethacrylates; Polymethacrylic Acids; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Acrylic Resins; Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: research coordinator
• Organization: Harboview

bagel@uw.edu

206.744.4406

Study Officials

• Claude Sagi

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Orthopedics

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 3, 2017
• Study Start: February 1, 2017
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: February 10, 2023
• Results First Posted: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)