chronOS Inject in Proximal Tibial Fractures

NCT02056834 | Completed Results

• 1 other identifier: STU-BIO-T-XX-004-04
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures.

Conditions

Closed Proximal Tibial Fracture Schatzker I - VI; Closed Proximal Tibial Fracture AO-OTA 41; Closed Proximal Tibial Fracture AO-OTA 42

Outcome Measures

Primary Outcomes (3)

• Fracture Union

  Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays

  12 months

• Articular Subsidence

  Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators

  12 months

• Mean Time to Union

  Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function

  12 months

Secondary Outcomes (13)

• Absorption Rate of Calcium Phosphate Cement

  12 months

• Patients Who Reached Full Weight Bearing

  12 months

• Total Range of Motion

  12 months

• Anatomical Gradings Assessed Radiographically

  12 months

• Patient's Satisfaction

  12 months

Study Arms (1)

chronOS Inject

Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect

Device: chronOS Inject

Interventions

chronOS Inject DEVICE

chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures

chronOS Inject

Eligibility Criteria

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

Study Population

Patients with proximal tibial fractures of type Schatzter I - VI, AO-OTA 41, AO-OTA 42 with bone defect are assessed for eligibility to enter the study. A computerized tomography is performed if necessary to confirm the fracture type and the amount of bone defect. Patients eligible for the study are followed over time to 12 months after surgery. A total of 30 patients who meet the inclusion/exclusion criteria are enrolled in the study, which is conducted at Kyungpook National University Hospital and Hanyang University Guri Hospital in the Republic of Korea.

You may qualify if:

• Subjects with closed proximal tibial fractures defined by : Tibia plateau, Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
• Skeletally mature adult 18 years or older, with close of growth plate at the time of surgery
• Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
• Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study

You may not qualify if:

• Open fractures with severe soft tissue damage
• Proximal tibial fractures with tumor or osteomyelitis
• Any tibial anatomy or disease process that would interfere with deployment or performance of the device as defined by the surgeon
• Known history of Paget's disease, osteomalacia, or any other metabolic bone disease
• Morbid obesity defined as a body mass index \>40 kg/m2 or weight more than 50 kg over ideal body weight
• Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy \>5 years
• Known or documented history of communicable disease, including AIDS and HIV
• Active Hepatitis (receiving medical treatment within two years)
• Active systemic or local infection
• Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing
• Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol)
• Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for \>1 month within last 12 months
• Pregnant or planning to become pregnant during study period
• Involved in study of another investigational product that may affect outcome
• History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales

Sponsors & Collaborators

• Synthes GmbH: lead

Study Sites (2)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Hanyang University Guri Hospital

Guri-si, 471-701, South Korea

Location

Results Point of Contact

• Title: Clinical Research Scientist Biomaterials
• Organization: Synthes GmbH

clinicalaffairs.emea@synthes.com

0041327204465

Study Officials

• Chang-Wug Oh, MD

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

• Kichul Park, MD

  Hanyang University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 6, 2014
• Study Start: March 1, 2010
• Primary Completion: September 30, 2012
• Study Completion: September 30, 2012
• Last Updated: March 3, 2025
• Results First Posted: June 25, 2014

Record last verified: 2025-02

Locations

KR (2)