Acute Scapholunate Injury Clinical Trial
Official title:
Multicenter Retrospective-prospective Short-term Evaluation of the SLIC Screw System in Subjects Requiring Treatment for Acute Scapholunate Injury
| Verified date | July 2017 |
| Source | Acumed, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 9 |
| Est. completion date | June 2017 |
| Est. primary completion date | June 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Subjects willing and able to comprehend and sign Informed Consent - Subjects who have received the SLIC screw as part of the treatment for scapholunate ligament repair or scapholunate reduction - Subjects with acute scapholunate injury, classified with Garcia-Elias Stage 1-4, OR Geissler Stage 1-3 - Subjects >18 years of age at the time of surgery Exclusion Criteria: - Subject diagnosed with chronic scapholunate injury - Subjects who underwent previous scapholunate procedure on the study wrist before implantation of the SLIC Screw System - Subjects with active or latent infection at the time of surgery - Subjects with sepsis at the time of surgery - Subjects diagnosed with osteoporosis at the time of surgery - Subjects with insufficient quantity and/or quality of bone - Subjects with cartilage degeneration on the bones at the time of surgery - Subjects with absence of potential for soft tissue healing at time of surgery, as documented by the investigator. - Female Subjects known to be pregnant - Subjects who were unable to follow postoperative care instructions, specifically, activity levels - Subjects who are unable or unwilling to return for postoperative study visits |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Acumed, LLC |
Aviles AJ, Lee SK, Hausman MR. Arthroscopic reduction-association of the scapholunate. Arthroscopy. 2007 Jan;23(1):105.e1-5. Epub 2006 Oct 16. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Garcia-Elias M. The treatment of wrist instability. J Bone Joint Surg Br. 1997 Jul;79(4):684-90. Review. — View Citation
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. — View Citation
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. — View Citation
Loredo RA, Sorge DG, Garcia G. Radiographic evaluation of the wrist: a vanishing art. Semin Roentgenol. 2005 Jul;40(3):248-89. Review. — View Citation
Opreanu RC, Baulch M, Katranji A. Reduction and maintenance of scapholunate dissociation using the TwinFix screw. Eplasty. 2009;9:e7. Epub 2009 Jan 29. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Time to planned explantation is operationally defined as the time in days between device implantation and planned removal of an intact device | 12 months | ||
| Primary | The proportion of devices where removal is attributed to healing and not device failure | 12 months | ||
| Secondary | Radiographic evaluation of device integrity | Device integrity defined as no device breakage or separation | 12 months | |
| Secondary | Radiographic evaluation of radiolucency | 12 months | ||
| Secondary | Radiographic evaluation of osteolysis | 12 months | ||
| Secondary | Complication rates over time | 12 months | ||
| Secondary | Comparison of range of motion in degrees from preoperative values | Flexion, Extension, Radial Deviation, Ulnar Deviation | 12 months | |
| Secondary | Comparison of grip strength in kg from preoperative values | 12 months | ||
| Secondary | Comparison of reported VAS pain from preoperative values | 12 months | ||
| Secondary | Subject satisfaction based on a five-point scale from preoperative | 12 months | ||
| Secondary | Comparison of scapholunate angle from preoperative through radiographic evaluation | 12 months | ||
| Secondary | Comparison of scapholunate joint space from preoperative through radiographic evaluation | 12 months |