Arthroscopic Assisted Open Reduction Internal Fixation Versus Open Reduction Internal Fixation in Ankle Fractures

Spectrum Health Hospitals

Status: Withdrawn

Conditions: Ankle Fractures

Treatments: Procedure: Open Reduction Internal Fixation; Procedure: Arthroscopic Assisted Open Reduction Internal Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT03084263

2017-061

Details and patient eligibility

About

The objective of this study is to compare the functional outcomes of patients with ankle fractures treated by Arthroscopic assisted Open Reduction Internal Fixation (AORIF) versus Open Reduction Internal Fixation (ORIF).

Full description

Prospective Randomized Clinical Trial evaluating patients with ankle fractures undergoing AORIF versus ORIF

Participants will be randomized into 2 different surgical groups, one group receiving only ORIF and the other group receiving AORIF.

As standard of care patients will follow up in the office at approximately 3 weeks, 6 weeks and 12 weeks post operatively. Patients will be immobilized in a splint and will be non-weight bearing until their 3 week post-op visit. At the 3 week post-op visit, the patient will be fitted in a boot, be instructed to begin self-directed ROM and to continue non-weight bearing. At the 6 week post-op visit, the patient will begin weight bearing in the boot.

In office study visit will occur at these same times. At each visit weight bearing status, return to sports, pain level, AOFAS and FAAM will be assessed. One additional study visit will be conducted over the phone or by mail at approximately one year post operatively and will consist of the FAAM.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Closed ankle fractures (44A, 44B, 44C)
• Ages of 18-65
• Men or women, including pregnant women
• Willing to consent

Exclusion criteria

• Open fractures
• Other lower extremity injuries/conditions that affects functional outcomes
• Problems maintaining follow up (homeless, not willing to return for follow up)
• Prisoners
• Unable to consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

AORIF of Ankle Fractures

Experimental group

Description:

Arthroscopic Assisted Open Reduction Internal Fixation of ankle fracture.

Treatment:

Procedure: Arthroscopic Assisted Open Reduction Internal Fixation

ORIF of Ankle Fractures

Active Comparator group

Description:

Open Reduction Internal Fixation of ankle fracture.

Treatment:

Procedure: Open Reduction Internal Fixation