Scaphoid Fracture Clinical Trial
Official title:
Functional Outcomes of Three Corner Fusion Without Triquetrum Excision Versus Conventional Four Corner Fusion in Scaphoid Non Union Advanced Collapse (SNAC) Wrist Grade II and III : a Prospective Randomized Controlled Trial
Verified date | May 2022 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigator compare two types of limited wrist arthrodesis used for management of cases with scaphoid non union advanced collapse (SNAC) as regard the outcome to provide the most suitable technique
Status | Completed |
Enrollment | 34 |
Est. completion date | December 2, 2021 |
Est. primary completion date | October 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - SNAC wrist G II , III Exclusion Criteria: - cases with radiolunate arthritis - Scapholunate advanced collapse - Grade 1 Scaphoid non union advanced collapse - Kienbock disease - Skeletally immature patients |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University , Faculty of medicine | Al 'Abbasiyah | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Bain GI, Sood A, Ashwood N, Turner PC, Fogg QA. Effect of scaphoid and triquetrum excision after limited stabilisation on cadaver wrist movement. J Hand Surg Eur Vol. 2009 Oct;34(5):614-7. doi: 10.1177/1753193408094923. Epub 2009 Jul 10. — View Citation
Delattre O, Goulon G, Vogels J, Wavreille G, Lasnier A. Three-Corner Arthrodesis With Scaphoid and Triquetrum Excision for Wrist Arthritis. J Hand Surg Am. 2015 Nov;40(11):2176-82. doi: 10.1016/j.jhsa.2015.07.032. Epub 2015 Sep 26. — View Citation
Scobercea RG, Budoff JE, Hipp JA. Biomechanical effect of triquetral and scaphoid excision on simulated midcarpal arthrodesis in cadavers. J Hand Surg Am. 2009 Mar;34(3):381-6. doi: 10.1016/j.jhsa.2008.11.027. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Range of motion | measuring range of motion and sagittal and coronal plane using goniometer | preoperative | |
Primary | Range of motion | measuring range of motion and sagittal and coronal plane using goniometer | one year postoperative | |
Primary | Power grip | Using dynamometer , take the average of three successive measures for injured side and normal side . The grip strength recorded as number between 1-30 (per square inch ) and as a percentage to the contralateral side | preoperative | |
Primary | Power grip | Using dynamometer , take the average of three successive measures for injured side and normal side . The grip strength recorded as number between 1-30 (per square inch ) and as a percentage to the contralateral side | one year postoperative | |
Secondary | operative time | measuring the operative time | Intraoperative | |
Secondary | Visual analogue scale | Pain assessment using the scale from 0 to 10 , with 0 no pain , 5 moderate pain , 10 worst possible pain | preoperative | |
Secondary | Visual analogue scale | Pain assessment using the scale from 0 to 10 , with 0 no pain , 5 moderate pain , 10 worst possible pain . | one year postoperative | |
Secondary | Patient satisfaction | Modified Mayo wrist score which involves both patient and physician participation. The scale runs from 0 to 100, with 0 representing a worse wrist condition and 100 suggesting a better wrist condition. It assess discomfort, active flexion/extension arc (in contrast to the contralateral side), grip strength (in comparison to the contralateral side), and the capacity to return to regular job or activities. | preoperative | |
Secondary | Patient satisfaction | Modified Mayo wrist score which involves both patient and physician participation. The scale runs from 0 to 100, with 0 representing a worse wrist condition and 100 suggesting a better wrist condition. It assess discomfort, active flexion/extension arc (in contrast to the contralateral side), grip strength (in comparison to the contralateral side), and the capacity to return to regular job or activities. | one year postoperative |
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