Ankle Syndesmosis Fixation by Antibiotic Releasing Bioabsorbable Screw

NCT01729195 | Completed Phase 2

• 2 other identifiers: A204-CI-1Protocol 15526
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center randomized trial evaluates the efficacy and safety of a new bone screw (antibiotic releasing bioabsorbable screw) in fixation of syndesmosis in patients with Weber C-type ankle fractures. The comparison is made to subjects treated by conventional metal screw fixation of the syndesmosis. The primary objective is to show that the antibiotic releasing bioabsorbable screw is at least as good as the routinely used metal screw in prevention of syndesmosis widening in patients with Weber C-type ankle fractures. The secondary objective is to show that the clinical outcome of the ankle fracture treatment is equal between patients treated by the antibiotic releasing bioabsorbable screw and the conventional metal screw.

Conditions

Ankle Fracture

Keywords

bioabsorbable implant; bone screw; local antibiotic prophylaxis; syndesmosis injury; ankle fracture; ciprofloxacin

Outcome Measures

Primary Outcomes (1)

• Radiostereometric analysis of the width of the syndesmosis

  Tantalum markers implanted during surgery into the fibula and tibia. Radiostereometric imaging allows to measure the three-dimensional displacement of the fibula in relation of the tibia.

  up to 12 weeks

Secondary Outcomes (1)

• Computed tomography in evaluation of the restoration of the normal anatomy

  Before surgery and repated at 0 and 12 weeks

Other Outcomes (3)

• Conventional radiographic evaluation

  Before surgery and at 0, 6, 12 and 52 weeks

• Systemic exposure to the released antibiotic

  6 weeks

• Functional recovery after ankle surgery

  Before surgery and at 12 and 52 weeks

Study Arms (1)

Single-arm

EXPERIMENTAL

The syndesmosis injury of the patients will be fixed with a ciprofloxacin containing bioabsorbable PLGA bone screw or a stainless steel metal screw

Procedure: A ciprofloxacin containing bioabsorbable PLGA bone screw

Interventions

A ciprofloxacin containing bioabsorbable PLGA bone screw PROCEDURE

The syndesmosis injury will be fixed the antibiotic releasing bioabsorbable bone screw or a standard metal screw. After surgery, the ankle will be immobilized in a cast for 6 weeks. The metal screw will be surgically removed at 8 weeks. The bioabsorbable screw will be left in place.

Also known as: Manufactured in Tampere University of Technology/Bioretec Ltd

Single-arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute, closed Weber C-type ankle fracture
• adult patients (age 18-70 years)
• female subjects of child-bearing potential must have a negative pregnancy test and an approved contraception for the study duration

You may not qualify if:

• a previous fracture or infection of the injured ankle or the ipsilateral foot
• significant associated soft-tissue injury
• other long-bone fracture of the lower extremities
• documented active infection at any anatomic site
• a known metabolic skeletal disease (osteoporosis or osteomalasia) or a medication affecting bone structure (such as corticosteroid treatment)
• a pathological fracture
• any underlying systemic disease (such as unbalanced diabetes mellitus or rheumatoid disease) or a condition (such as alcoholism or drug abuse) which are known to affect resistance to infection
• history of prosthetic knee or hip replacement
• pregnant women or nursing mothers
• hypersensitivity to fluoroquinolones or related antibiotics (nalidixine acid)
• any other condition that in the judgment of the investigator would prohibit the subject from participating in the study or may hinder the collection of data and interpretation of the results

Sponsors & Collaborators

• Turku University Hospital: lead
• Tampere University of Technology: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (4)

• Makinen TJ, Veiranto M, Knuuti J, Jalava J, Tormala P, Aro HT. Efficacy of bioabsorbable antibiotic containing bone screw in the prevention of biomaterial-related infection due to Staphylococcus aureus. Bone. 2005 Feb;36(2):292-9. doi: 10.1016/j.bone.2004.11.009.

  PMID: 15780955 BACKGROUND

• Makinen TJ, Mattila KT, Maattanen H, Aro HT. Comparison of digital and conventional radiostereometric image analysis in an ankle phantom model. Scand J Surg. 2005;94(3):233-8. doi: 10.1177/145749690509400311.

  PMID: 16259174 BACKGROUND

• Niemela SM, Ikaheimo I, Koskela M, Veiranto M, Suokas E, Tormala P, Waris T, Ashammakhi N, Syrjala H. Ciprofloxacin-releasing bioabsorbable polymer is superior to titanium in preventing Staphylococcus epidermidis attachment and biofilm formation in vitro. J Biomed Mater Res B Appl Biomater. 2006 Jan;76(1):8-14. doi: 10.1002/jbm.b.30414.

  PMID: 16265660 BACKGROUND

• Veiranto M, Tormala P, Suokas E. In vitro mechanical and drug release properties of bioabsorbable ciprofloxacin containing and neat self-reinforced P(L/DL)LA 70/30 fixation screws. J Mater Sci Mater Med. 2002 Dec;13(12):1259-63. doi: 10.1023/a:1021187331458.

  PMID: 15348674 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Hannu T Aro, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 20, 2012
• Study Start: March 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2014
• Last Updated: February 17, 2014

Record last verified: 2014-02

Locations

FI (1)