Short Term Evaluation of SLIC Screw in Treatment of Scapholunate Injury

Multicenter Retrospective-prospective Short-term Evaluation of the SLIC Screw System in Subjects Requiring Treatment for Acute Scapholunate Injury

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.

Study Overview

• Status: Terminated
• Conditions: Acute Scapholunate Injury
• Intervention / Treatment: Device: Acumed Scapholunate Intercarpal Screw

• Study Type: Observational
• Enrollment (Actual): 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients from selected sites with acute scapholunate injury fulfilling inclusion and exclusion criteria

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Acumed, LLC
• Investigators: Principal Investigator: Robert S Unsell, MD, Community Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Opreanu RC, Baulch M, Katranji A. Reduction and maintenance of scapholunate dissociation using the TwinFix screw. Eplasty. 2009;9:e7. Epub 2009 Jan 29.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 14013