An interventional study of Early Weight bearing + Cam Boot and Non-Weight Bearing + Cam Boot in Ankle Fracture, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-03.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
The purpose of this randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery.
Patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. After surgery patients will be randomized to either weight bearing as tolerated at two weeks with a cam boot or non-weight bearing with a cam boot. Randomization will be performed by number allocation with odd numbers in the early weight bearing group and even numbers in the non-weight bearing group. The surgeon will be blinded to this until after the surgery. The patients will all be placed in a short leg cast post operative and made non-weight bearing for 2 weeks until sutures are removed which is current standard treatment. Both groups will be asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is non weight bearing in a cam boot, the latter being standard treatment.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 107 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Early Weight bearing + Cam Boot
Procedure: Non-Weight Bearing + Cam Boot
Patients will be transitioned to weight bearing as tolerated in a cam boot.
Subject will be transitioned to non weight bearing cam boot, standard treatment.
Olerud Molander Ankle Score
The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.
Time frame: 1 year
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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NYU Langone Health