Short Term Evaluation of SLIC Screw in Treatment of Scapholunate Injury

NCT02579694 | Terminated

• 1 other identifier: 14013
• Study Type: observational
• Target: 9
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Scapholunate Injury

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Radiographic evaluation of device integrity

  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

  12 months

Interventions

Acumed Scapholunate Intercarpal Screw DEVICE

Evaluation of provisional fixation to allow biologic healing of the scapholunate interval

Also known as: SLIC Screw

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acumed, LLC: lead

Related Publications (11)

• 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.

  PMID: 15465234 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.

  PMID: 21732026 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.

  PMID: 17210436 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.

  PMID: 22913993 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.

  PMID: 16609495 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.

  PMID: 1891931 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.

  PMID: 19252680 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.

  PMID: 21700650 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.

  PMID: 22022028 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.

  PMID: 16060116 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.

  PMID: 9250766 BACKGROUND

Study Officials

• Robert S Unsell, MD

  Community Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 20, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07