Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559111
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
RCT of Cast or Functional Ankle Orthosis After Ankle Fracture Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Postoperative Care After Operatively Treated Ankle Fractures With Cast or Functional Ankle Orthosis A 2-year Prospective Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized clinical trial was to compare the effect of 6-week casting versus 2-week casting followed by 4-week ankle bracing in adult patients with surgically treated ankle fractures
The primary outcome measures used were the functional results 3 months after surgery evaluated using two functional outcome measures Olerud and Molander score OMAS and Kaikkonen et al score and the patient return to work
In the casting group the traditional plaster was changed to a fiberglass one at 2 weeks and the cast treatment continued until 6 weeks In the functional treatment group the traditional plaster cast was changed to an reusable semi-rigid plastic orthosis Aircast at 2 weeks after surgery and its use was continued as an ankle support for up to 6 weeks Follow-ups including subjective and objective evaluations were at 2 6 12 and 52 weeks and at 2 years postoperatively
The primary outcome measures used were the functional results 3 months after surgery evaluated using two functional outcome measures Olerud and Molander score OMAS and Kaikkonen et al score and the patient return to work
In the casting group the traditional plaster was changed to a fiberglass one at 2 weeks and the cast treatment continued until 6 weeks In the functional treatment group the traditional plaster cast was changed to an reusable semi-rigid plastic orthosis Aircast at 2 weeks after surgery and its use was continued as an ankle support for up to 6 weeks Follow-ups including subjective and objective evaluations were at 2 6 12 and 52 weeks and at 2 years postoperatively
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None