Surgical outcome of lower extremity reconstruction using hydroxyapatite

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0003714

Enrollment

Registered

2019-04-04

Start date

2017-12-13

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Product name: Bone gros Component: hydroxiapatite Graft material for bone defect site Product name: allo bone chip Component: allogenous bone Graft material for bone defect site

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients less than 40-75 years old (For the patients who are under age, the consent from their patients or legal representative is required) Patients who need bone substitute on bone graft due to gap filling Patients who want to apply bone substitute besides autologous bone for bone graft Patients who agreed and signed the informed consent

Exclusion criteria

Exclusion criteria: Patients with metabolic bone tumor Patient with fracture Patients who cannot understand the study (illiterate, foreigner, demented patient, etc.) Patients who cannot participate in the study, in investigator’s opinion Patients who has contraindication disease (severe heart disease, severe liver disease, infectious disease, hematologic disease, long time steroid user, antiplatelet user, etc)

Design outcomes

Primary

Measure	Time frame
Visual analog scale(VAS) score;Knee society score;The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) score	—

Secondary

Measure	Time frame
Computed Tomography (CT): union;X-ray (Osteoconductivity, absorbability)	—

Countries

Korea, Republic of

Contacts

Public ContactSeung Hoon Lee

Seoul National University Bundang Hospital

lsh5931k@hanmail.net+82-31-787-7201

Outcome results