Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants

• Sponsor: National Police Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01431560
• Collaborator: (none)
• Enrollment: 109
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate and screws for ankle fracture are not different from those of metallic implants.

Condition or Disease	Intervention/Treatment	Phase
Ankle Fracture	Device: fixation of the ankle fracture (Solco ); Device: fixation of the ankle fracture (Freedom)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: metallic implant fixation of the ankle fracture with metallic implants	Device: fixation of the ankle fracture (Solco ); fixation with metallic implant; Other Names: metallic implant: Solco
Active Comparator: biodegradable implant fixation of the ankle fracture with Freedom plate and screws	Device: fixation of the ankle fracture (Freedom); fixation with biodegradable implant; Other Names: biodegradable implant: Freedom

Outcome Measures

Primary Outcome Measures

1. American Orthopaedic Foot and Ankle Society(AOFAS) score [3 months, 6 months, 1 year]

   change from baseline(3 months after surgery)

Secondary Outcome Measures

1. Short Musculoskeletal Functional Assessment(SMFA) scale [3 months, 6 months, 1 year]

   change from baseline (3 months after surgery)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• skeletally mature subjects (≥16 years old) with unilateral ankle fractures

Exclusion Criteria:

• subjects less than 16 years old,

• subjects not followed up at this hospital,

• multiple injuries,

• bilateral ankle fractures,

• open fractures,

• pathologic fractures,

• concomitant tibial shaft fractures,

• previous history of immobilization due to significant injury or a fracture of either ankle,

• significant peripheral neuropathy,

• soft tissue infection in the region on either injured ankle,

• or inability to complete the study protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Police Hospital	Seoul		Korea, Republic of	138-708

Sponsors and Collaborators

• National Police Hospital

Investigators

• Principal Investigator: Jung Ho Noh, M.D., Ph.D., National Police Hospital, Korea, Republic of

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jung Ho Noh, Orthopaedic Surgeon, National Police Hospital
• ClinicalTrials.gov Identifier: NCT01431560
• Other Study ID Numbers: National Police Hospital
• First Posted: Sep 9, 2011
• Last Update Posted: Sep 9, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Jung Ho Noh, Orthopaedic Surgeon, National Police Hospital: ankle; metallic; biodegradable; Freedom
• Additional relevant MeSH terms: Fractures, Bone; Ankle Fractures

Study Results

No Results Posted as of Sep 9, 2011