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Difficulties finding subjects meeting enrollment criteria
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The purpose of this retrospective-prospective clinical evaluation is to determine whether the SLIC Screw System provides provisional fixation to allow biological healing of the scapholunate interval.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acumed Scapholunate Intercarpal Screw | Device | Evaluation of provisional fixation to allow biologic healing of the scapholunate interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of reported VAS pain from preoperative to post-planned explantation | Planned removal of provisional device recommended between six and 9 months; 12-month analysis will capture time to planned removal. | 12 months |
| Time to planned explantation is operationally defined as the time in days between device implantation and planned removal of an intact device | 12 months | |
| The proportion of devices where removal is attributed to healing and not device failure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic evaluation of device integrity | Device integrity defined as no device breakage or separation | 12 months |
| Radiographic evaluation of radiolucency | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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All patients from selected sites with acute scapholunate injury fulfilling inclusion and exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Unsell, MD | Community Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15465234 | Background | Zarkadas PC, Gropper PT, White NJ, Perey BH. A survey of the surgical management of acute and chronic scapholunate instability. J Hand Surg Am. 2004 Sep;29(5):848-57. doi: 10.1016/j.jhsa.2004.05.008. | |
| 21732026 | Background | Caloia M, Caloia H, Pereira E. Arthroscopic scapholunate joint reduction. Is an effective treatment for irreparable scapholunate ligament tears? Clin Orthop Relat Res. 2012 Apr;470(4):972-8. doi: 10.1007/s11999-011-1953-4. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 11, 2018 | |
| Reset | Oct 18, 2018 | |
| Release | Oct 18, 2018 | |
| Reset | Nov 14, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 11, 2018 | Oct 18, 2018 | |||
| Oct 18, 2018 |
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| Radiographic evaluation of osteolysis | 12 months |
| Complication rates over time | 12 months |
| Comparison of range of motion in degrees from preoperative values | Flexion, Extension, Radial Deviation, Ulnar Deviation | 12 months |
| Comparison of grip strength in kg from preoperative values | 12 months |
| Comparison of reported VAS pain from preoperative values | 12 months |
| Subject satisfaction based on a five-point scale from preoperative | 12 months |
| Comparison of scapholunate angle from preoperative through radiographic evaluation | 12 months |
| Comparison of scapholunate joint space from preoperative through radiographic evaluation | 12 months |
| 17210436 | Background | Aviles AJ, Lee SK, Hausman MR. Arthroscopic reduction-association of the scapholunate. Arthroscopy. 2007 Jan;23(1):105.e1-5. doi: 10.1016/j.arthro.2006.07.013. Epub 2006 Oct 16. |
| 22913993 | Background | Larson TB, Gaston RG, Chadderdon RC. The use of temporary screw augmentation for the treatment of scapholunate injuries. Tech Hand Up Extrem Surg. 2012 Sep;16(3):135-40. doi: 10.1097/BTH.0b013e318257595b. |
| 16609495 | Background | Rosenwasser MP, Miyasajsa KC, Strauch RJ. The RASL procedure: reduction and association of the scaphoid and lunate using the Herbert screw. Tech Hand Up Extrem Surg. 1997 Dec;1(4):263-72. No abstract available. |
| 1891931 | Background | Herbert TJ. Acute rotary dislocation of the scaphoid: a new technique of repair using Herbert screw fixation across the scapho-lunate joint. World J Surg. 1991 Jul-Aug;15(4):463-9. doi: 10.1007/BF01675642. |
| 19252680 | Background | Opreanu RC, Baulch M, Katranji A. Reduction and maintenance of scapholunate dissociation using the TwinFix screw. Eplasty. 2009;9:e7. Epub 2009 Jan 29. |
| 21700650 | Background | Cognet JM, Levadoux M, Martinache X. The use of screws in the treatment of scapholunate instability. J Hand Surg Eur Vol. 2011 Oct;36(8):690-3. doi: 10.1177/1753193411410154. Epub 2011 Jun 23. |
| 22022028 | Background | Bhat AK, Kumar B, Acharya A. Radiographic imaging of the wrist. Indian J Plast Surg. 2011 May;44(2):186-96. doi: 10.4103/0970-0358.85339. |
| 16060116 | Background | Loredo RA, Sorge DG, Garcia G. Radiographic evaluation of the wrist: a vanishing art. Semin Roentgenol. 2005 Jul;40(3):248-89. doi: 10.1053/j.ro.2005.01.014. No abstract available. |
| 9250766 | Background | Garcia-Elias M. The treatment of wrist instability. J Bone Joint Surg Br. 1997 Jul;79(4):684-90. doi: 10.1302/0301-620x.79b4.14192. No abstract available. |
| Nov 14, 2018 |