A Comparison of Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries (Lisfranc)
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ClinicalTrials.gov Identifier: NCT00689962 |
Recruitment Status :
Completed
First Posted : June 4, 2008
Last Update Posted : January 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Joint Instability | Device: Linvatec 4.5 mm Smart Screw Device: Synthes 4.0 mm steel screw | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Prospective Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Patients with unstable Lisfranc foot fracture-dislocations that receive bioabsorbable screw fixation through surgery.
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Device: Linvatec 4.5 mm Smart Screw
Linvatec 4.5 mm Smart Screw to surgically fix the foot's Lisfranc ligaments |
Active Comparator: 2
Patients with unstable Lisfranc fracture-dislocations of the foot that receive steel screw fixation through surgery.
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Device: Synthes 4.0 mm steel screw
Standard steel screw use to surgically fix the foot's Lisfranc ligaments. |
- Foot and Ankle Ability Measures [ Time Frame: 3 years ]
- Visual Analog Score for pain [ Time Frame: 3 years ]
- X-rays for maintained healing [ Time Frame: 3 years ]
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects will be adults of any gender or race.
- Subjects will be adults between 18 and 75 years of age.
- The underlying diagnosis will be a Lisfranc foot injury.
- The indication for fixing the Lisfranc ligaments is abnormal separation of the middle part of the foot from each other.
- Subjects will have received either a steel or absorbable screw to fix the Lisfranc ligaments.
Exclusion Criteria:
- Subjects may not have any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures.
- Subjects may not have a history of known alcohol, analgesic, or narcotic substance abuse within 12 months prior to pretreatment.
- Subjects may not have a history of severe psychiatric illness such as depression or psychosis that may influence the results of administered outcome questionnaires.
- Subjects may not be pregnant.
- Subjects may be excluded from this study for any reason that may pose unnecessary risk or confounding of data, in the judgment of the investigator. This includes the 4 above points.
- Subjects must not have intact or normal Lisfranc ligaments in the foot.
- Subjects may not have a history of deep Lisfranc joint infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689962
United States, Pennsylvania | |
Riddle Memorial Hospital | |
Media, Pennsylvania, United States, 19063 | |
Nazareth Hospital | |
Philadelphia, Pennsylvania, United States, 19152 |
Principal Investigator: | Jamal Ahmad, M.D. | Rothman Institute Orthopaedics |
Responsible Party: | Jamal Ahmad, Assistant Professor of Orthopaedic Surgery, Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT00689962 |
Other Study ID Numbers: |
Lisfranc 1 |
First Posted: | June 4, 2008 Key Record Dates |
Last Update Posted: | January 18, 2017 |
Last Verified: | January 2017 |
Lisfranc fracture dislocation bioabsorbable |
Joint Instability Foot Injuries Joint Diseases |
Musculoskeletal Diseases Leg Injuries Wounds and Injuries |