Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, 49525, United States
NCT Number: NCT03812237
A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing versus Non Weight Bearing Following Modified Lapidus Arthrodesis
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Grand Rapids, Michigan, 49525, United States
The purpose of this prospective randomized control trial is to assess outcomes in patients who undergo modified Lapidus arthrodesis and whose postoperative management includes early weight bearing on heel (in a boot) and compare it to standard of care non weight bearing post operative management.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient were permitted to progressively weightbear on their heel at 2 week post-op.
Other names: EWB
Time frame: 6 months
To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation.
Time frame: 12 months
Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period.] AOFAS Scale: [0 (no function/severe deformity) to 83 (full function/no limitations/deformity)]
Time frame: 12 months
Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. SMFA Scale: 101 items scored 1 to 5 [1( problems/no difficulty/not bothered) - 5 (unable to do task/symptoms constantly/extremely bothered)]
Time frame: 12 months
Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: [0 (no pain) - 10 (worse possible pain)]
Time frame: 12 months
Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. FFIr Scale: 67 items scored 1 to 7 [1(no problems/no difficulty/not bothered) - 6 (unable to do a task/symptoms all the time/worst pain imaginable) - 7 (Not applicable)]. Score range: 46 to 230.
Time frame: 12 months
Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. SF-36 v.2 Scale: Self-reporting outcomes assessment [0 (no function/severe physical/mental disability) to 100 (full function, no limitations to mental/physical health)]. Score range: 46 to 230.
Orthopaedic Associates of Michigan, PC
Other
A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing Versus Non-Weight Bearing Following Modified Lapidus Arthrodesis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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