Ignite Creation Date:
2024-05-06 @ 8:49 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02827006
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2016-06-27
Brief Title:
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects A 2 Year Prospective Randomised Study on Distal Radius Osteotomies
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects
Detailed Description:
Background A bone graft from the iliac crest has long been the gold standard for filling voids in opening wedge osteotomies CaP bone cement has been considered the possible alternative to bone graft
Methods 20 adult patients with distal radius malunions and dorsal deformities were randomised intra-operatively to bone graft 10 or CaP bone cement 10 Dorsal titanium locking plates were used and the wrist was stabilised in a cast for 8 weeks Follow-ups for 24 months included VAS on wrist and iliac crest grip strength ROM bilaterally Quick-DASH and Gartland Werleys functional scoring system X-rays and CT scans were taken at 8 wks 3-6-12-24 mths
Methods 20 adult patients with distal radius malunions and dorsal deformities were randomised intra-operatively to bone graft 10 or CaP bone cement 10 Dorsal titanium locking plates were used and the wrist was stabilised in a cast for 8 weeks Follow-ups for 24 months included VAS on wrist and iliac crest grip strength ROM bilaterally Quick-DASH and Gartland Werleys functional scoring system X-rays and CT scans were taken at 8 wks 3-6-12-24 mths
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