Utility of Postoperative Bracing

Duke University

Status: Completed

Conditions: Postoperative Bracing for Spinal Deformity

Treatments: Other: No Bracing; Other: Thoracolumbosacral (TLSO) brace

Study type: Interventional

Funder types: Other

Identifiers

NCT03947541

Pro00100497

Details and patient eligibility

About

The study is being done to assess if the use of bracing helps improve quality of life of patients that are undergoing a spinal fusion for deformity.

If the participant agrees to be in this trial they will be randomly assigned (like the flip of a coin) to receive either brace treatment or non-brace treatment.

Regardless of what treatment group the participants are in, they will undergo surgery as planned. After surgery, patients in both groups will be treated per standard of care.

Enrollment: 14 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The principal investigator's new or returning patients
• Adults 18 to 80 years of old
• Undergoing a spinal fusion procedure of greater than or equal to 5 levels for the purpose of correcting idiopathic spinal deformity

Exclusion criteria

• Patients who are undergoing a spinal fusion for other reasons besides deformity
• Patients who are unable to provide consent or fill out survey questionnaires
• Patients who have brace-prohibitive body habitus
• Patients who are unable to obtain standing AP and lateral 3-foot standing scoliosis x-rays

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

No Brace

Active Comparator group

Description:

Patients randomized to the no-brace group will not be required to wear a brace, postoperatively.

Treatment:

Other: No Bracing

Brace

Experimental group

Description:

Patients randomized to the brace group will wear the brace when out of bed and will be allowed to remove the brace when in bed. This intervention will continue through their 6-week postoperative visit, after which point, patients will be allowed to wear the brace for comfort.

Treatment:

Other: Thoracolumbosacral (TLSO) brace