Clinical trial NCT02579694: Short Term Evaluation of SLIC Screw in Treatment of Scapholunate Injury
Official title: Multicenter Retrospective-prospective Short-term Evaluation of the SLIC Screw System in Subjects Requiring Treatment for Acute Scapholunate Injury
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Scapholunate Injury
Lead sponsor: Acumed, LLC
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from selected sites with acute scapholunate injury fulfilling inclusion and exclusion criteria

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of reported VAS pain from preoperative to post-planned explantation
timeFrame: 12 months
measure: Time to planned explantation is operationally defined as the time in days between device implantation and planned removal of an intact device
timeFrame: 12 months
measure: The proportion of devices where removal is attributed to healing and not device failure
timeFrame: 12 months
Secondary outcomes:
measure: Radiographic evaluation of device integrity
timeFrame: 12 months
measure: Radiographic evaluation of radiolucency
timeFrame: 12 months
measure: Radiographic evaluation of osteolysis
timeFrame: 12 months
measure: Complication rates over time
timeFrame: 12 months
measure: Comparison of range of motion in degrees from preoperative values
timeFrame: 12 months
measure: Comparison of grip strength in kg from preoperative values
timeFrame: 12 months
measure: Comparison of reported VAS pain from preoperative values
timeFrame: 12 months
measure: Subject satisfaction based on a five-point scale from preoperative
timeFrame: 12 months
measure: Comparison of scapholunate angle from preoperative through radiographic evaluation
timeFrame: 12 months
measure: Comparison of scapholunate joint space from preoperative through radiographic evaluation
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Community Hospital
name: Robert S Unsell, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.jhsa.2004.05.008.
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.
citation: 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.
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.
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. No abstract available.
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. doi: 10.1007/BF01675642.
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.
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.
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.
citation: 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.
citation: 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.