Medial Malleolus FracturesNCT03061279
Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures
A study testing Fixation by Acutrak headless screw and Fixation by headed screws, plates, and or wires in people with Medial Malleolus Fractures, run by Stanford University at 3 sites in United States.
Trial summary
The purpose of this study is assess the safety and efficacy of Acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medial Malleolus Fractures
- What is being tested?
- Fixation by Acutrak headless screw and Fixation by headed screws, plates, and or wires
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2017to 26 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ankle fractures that undergo open reduction internal fixation of the medial malleolus
Who cannot join
- Tibial plafond (pilon) fractures
- Medial malleolar osteotomies to access the talus, perform an ankle fusion, or deal with a pathologic lesion, osteonecrosis, or infection due to their diversity in diagnosis, management, and weight bearing status
- Patients with prior surgical treatment of the ankle for fracture, deformity, infection, neoplasia, or other pathologic process on the ipsilateral extremity
- Patients that are non-weight bearing on one or both lower extremities prior to sustaining their ankle injury
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brigham and Women's Hospital,
Boston, Massachusetts, 02115
Stanford University School of Medicine
Palo Alto, California, 94063
Kaiser Hospital
Sacramento, California, 95823
About this study
Official title: Randomized Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures
The purpose of this study is assess the safety and efficacy of Acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint.
The investigators hope to learn the following objectives from this study
Read more
- Prospectively establish equivalence with respect to fracture union rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
- Prospectively establish equivalence with respect Patient Reported Outcome Measurement Information System (PROMIS) scores after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
- Prospectively establish superiority with respect to hardware related pain after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
- Prospectively establish superiority with respect to the hardware removal rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
Patients scheduled for open reduction and internal fixation for medial malleolus fracture by using Acutrak headless screw or any other method will be asked to enroll by the attending physician, and those patients will be asked to consent to the study. Patients will be randomized by sealed envelope to surgical fixation with traditional headed screws, plates, and wires or Acutrak headless compression screws. At the time of randomization, the fracture pattern and severity, past medical history and medications, and demographic data will be documented. After operative fixation, patients will receive routine fracture follow-up with a clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete the PROMIS and Visual Analogue Pain Scale (VAS) scores to 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgical fixation
- Conditions
- Medial Malleolus Fractures
- Being tested
- Fixation by Acutrak headless screw, Fixation by headed screws, plates, and or wires
- Keywords
- Medial Malleolus fractures, headless screws, headed screws
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixation by Acutrak headless screwDevice
Also called Acutrak 2 Headless Compression Screw System
The fixation provided by the Acutrak headless compression screws provide sufficient fixation to achieve union and a favorable clinical outcome in both horizontal and vertical medial malleolus fractures when compared to bicortical and unicortical screw fixation, tension band wiring, and mini-fragment or buttress plating
Fixation by headed screws, plates, and or wiresDevice
DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes Locking contrast dynamic compression (LC-DCP) Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire are the alternative methods of treatment of medial malleolus fracture.
| Study group | Role | What they receive |
|---|---|---|
| Fixation by Acutrak headless screw | Experimental | Not described Receives: Device: Fixation by Acutrak headless screw |
| Fixation by headed screws, plates and or wire | Active comparator | DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes LC-DCP Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire. Receives: Device: Fixation by headed screws, plates, and or wires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Severity of Hardware Related Pain Localized to the Medial Malleolus at One Year After Sustaining an Ankle Fracture.
Pain on a visual analogue scale (range: 0 to 1; 0 = no pain; 10 = worst pain imaginable).
Measured: Baseline, year 1
Secondary outcomes (6)
Fracture Union Rate at One Year After Sustaining an Ankle Fracture.
Fracture union rate assessed by radiographic imaging.
Measured: Month 3
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Lower Extremity Function Scale (LEFS)
The PROMIS LEFS scale consists of 20 questions, each on a 5-point Likert scale (0 = extreme difficulty, 4 = no difficulty). Questions are summed for a total score.
Measured: Baseline, year 2
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Depression
The PROMIS depression score is based on an adaptive test, and reported as a cumulative T-score with standard error.
Measured: Baseline, year 2
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Pain Interference
The PROMIS pain interference score is based on an adaptive test, and reported as a cumulative T-score with standard error.
Measured: Baseline, year 2
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Physical Function
The PROMIS physical function score is based on an adaptive test, and reported as a cumulative T-score with standard error.
Measured: Baseline, year 2
Amount Pain Medication Required During Recovery Period
Pain medication measured in morphine equivalents.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Apr 2017
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
Why it stopped: Problem negotiating other sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Medial Malleolus FracturesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Amanatullah, Stanford University
- Investigators
- Derek Amanatullah, MD, Study director, Stanford University School of Medicine, CAMicheal Weaver, MD, Principal investigator, Brigham and Women's Hospital, Harvard Medical School, Boston, MADomingo Hallare, MD, Principal investigator, Kaiser Permanente Hospital, South Sacramento, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061279
- Sponsor's protocol ID
- 37630
- Status last verified
- Sep 2020
- First submitted
- 11 Feb 2017
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rovinsky D, Haskell A, Liu Q, Paiement GD, Robinovitch S. Evaluation of a new method of small fragment fixation in a medial malleolus fracture model. J Orthop Trauma. 2000 Aug;14(6):420-5. doi: 10.1097/00005131-200008000-00007.
PubMed 11001416Toolan BC, Koval KJ, Kummer FJ, Sanders R, Zuckerman JD. Vertical shear fractures of the medial malleolus: a biomechanical study of five internal fixation techniques. Foot Ankle Int. 1994 Sep;15(9):483-9. doi: 10.1177/107110079401500905.
PubMed 7820240Amanatullah DF, McDonald E, Shellito A, Lafazan S, Cortes A, Curtiss S, Wolinsky PR. Effect of mini-fragment fixation on the stabilization of medial malleolus fractures. J Trauma Acute Care Surg. 2012 Apr;72(4):948-53. doi: 10.1097/TA.0b013e318249697d.
PubMed 22491610Amanatullah DF, Wolinsky PR. An alternative fixation technique for small medial malleolus fractures. Orthopedics. 2010 Dec;33(12):888. doi: 10.3928/01477447-20101021-17. No abstract available.
PubMed 21117562Dumigan RM, Bronson DG, Early JS. Analysis of fixation methods for vertical shear fractures of the medial malleolus. J Orthop Trauma. 2006 Nov-Dec;20(10):687-91. doi: 10.1097/01.bot.0000247075.17548.3a.
PubMed 17106379Amanatullah DF, Khan SN, Curtiss S, Wolinsky PR. Effect of divergent screw fixation in vertical medial malleolus fractures. J Trauma Acute Care Surg. 2012 Mar;72(3):751-4. doi: 10.1097/TA.0b013e31823b8b9f.
PubMed 22491565Brown OL, Dirschl DR, Obremskey WT. Incidence of hardware-related pain and its effect on functional outcomes after open reduction and internal fixation of ankle fractures. J Orthop Trauma. 2001 May;15(4):271-4. doi: 10.1097/00005131-200105000-00006.
PubMed 11371792Hung M, Baumhauer JF, Latt LD, Saltzman CL, SooHoo NF, Hunt KJ; National Orthopaedic Foot & Ankle Outcomes Research Network. Validation of PROMIS (R) Physical Function computerized adaptive tests for orthopaedic foot and ankle outcome research. Clin Orthop Relat Res. 2013 Nov;471(11):3466-74. doi: 10.1007/s11999-013-3097-1.
PubMed 23749433
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures
- ClinicalTrials.gov ID
- NCT03061279
- Acronym / sponsor ID
- 37630
- Conditions
- Medial Malleolus Fractures
- Keywords
- Medial Malleolus fractures, headless screws, headed screws
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problem negotiating other sites
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 2 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is assess the safety and efficacy of Acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint.
The investigators hope to learn the following objectives from this study
- Prospectively establish equivalence with respect to fracture union rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
- Prospectively establish equivalence with respect Patient Reported Outcome Measurement Information System (PROMIS) scores after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
- Prospectively establish superiority with respect to hardware related pain after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
- Prospectively establish superiority with respect to the hardware removal rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
Patients scheduled for open reduction and internal fixation for medial malleolus fracture by using Acutrak headless screw or any other method will be asked to enroll by the attending physician, and those patients will be asked to consent to the study. Patients will be randomized by sealed envelope to surgical fixation with traditional headed screws, plates, and wires or Acutrak headless compression screws. At the time of randomization, the fracture pattern and severity, past medical history and medications, and demographic data will be documented. After operative fixation, patients will receive routine fracture follow-up with a clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete the PROMIS and Visual Analogue Pain Scale (VAS) scores to 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgical fixation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixation by Acutrak headless screw | Experimental | Device: Fixation by Acutrak headless screw |
| Fixation by headed screws, plates and or wire | Active comparator | Device: Fixation by headed screws, plates, and or wiresDePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes LC-DCP Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ankle fractures that undergo open reduction internal fixation of the medial malleolus
Key exclusion criteria (4 listed)
- Tibial plafond (pilon) fractures
- Medial malleolar osteotomies to access the talus, perform an ankle fusion, or deal with a pathologic lesion, osteonecrosis, or infection due to their diversity in diagnosis, management, and weight bearing status
- Patients with prior surgical treatment of the ankle for fracture, deformity, infection, neoplasia, or other pathologic process on the ipsilateral extremity
- Patients that are non-weight bearing on one or both lower extremities prior to sustaining their ankle injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixation by Acutrak headless screwAlso: Acutrak 2 Headless Compression Screw SystemThe fixation provided by the Acutrak headless compression screws provide sufficient fixation to achieve union and a favorable clinical outcome in both horizontal and vertical medial malleolus fractures when compared to bicortical and unicortical screw fixation, tension band wiring, and mini-fragment or buttress plating | Device | Fixation by Acutrak headless screw |
| Fixation by headed screws, plates, and or wiresDePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes Locking contrast dynamic compression (LC-DCP) Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire are the alternative methods of treatment of medial malleolus fracture. | Device | Fixation by headed screws, plates and or wire |
Primary outcome
Change in Severity of Hardware Related Pain Localized to the Medial Malleolus at One Year After Sustaining an Ankle Fracture.
Time frame: Baseline, year 1
Pain on a visual analogue scale (range: 0 to 1; 0 = no pain; 10 = worst pain imaginable).
6 secondary outcomes
Fracture Union Rate at One Year After Sustaining an Ankle Fracture.
Time frame: Month 3
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Lower Extremity Function Scale (LEFS)
Time frame: Baseline, year 2
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Depression
Time frame: Baseline, year 2
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Pain Interference
Time frame: Baseline, year 2
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Physical Function
Time frame: Baseline, year 2
Amount Pain Medication Required During Recovery Period
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11001416Rovinsky D, Haskell A, Liu Q, Paiement GD, Robinovitch S. Evaluation of a new method of small fragment fixation in a medial malleolus fracture model. J Orthop Trauma. 2000 Aug;14(6):420-5. doi: 10.1097/00005131-200008000-00007.
- Background: PubMed 7820240Toolan BC, Koval KJ, Kummer FJ, Sanders R, Zuckerman JD. Vertical shear fractures of the medial malleolus: a biomechanical study of five internal fixation techniques. Foot Ankle Int. 1994 Sep;15(9):483-9. doi: 10.1177/107110079401500905.
- Background: PubMed 22491610Amanatullah DF, McDonald E, Shellito A, Lafazan S, Cortes A, Curtiss S, Wolinsky PR. Effect of mini-fragment fixation on the stabilization of medial malleolus fractures. J Trauma Acute Care Surg. 2012 Apr;72(4):948-53. doi: 10.1097/TA.0b013e318249697d.
- Background: PubMed 21117562Amanatullah DF, Wolinsky PR. An alternative fixation technique for small medial malleolus fractures. Orthopedics. 2010 Dec;33(12):888. doi: 10.3928/01477447-20101021-17. No abstract available.
- Background: PubMed 17106379Dumigan RM, Bronson DG, Early JS. Analysis of fixation methods for vertical shear fractures of the medial malleolus. J Orthop Trauma. 2006 Nov-Dec;20(10):687-91. doi: 10.1097/01.bot.0000247075.17548.3a.
- Background: PubMed 22491565Amanatullah DF, Khan SN, Curtiss S, Wolinsky PR. Effect of divergent screw fixation in vertical medial malleolus fractures. J Trauma Acute Care Surg. 2012 Mar;72(3):751-4. doi: 10.1097/TA.0b013e31823b8b9f.
- Background: PubMed 11371792Brown OL, Dirschl DR, Obremskey WT. Incidence of hardware-related pain and its effect on functional outcomes after open reduction and internal fixation of ankle fractures. J Orthop Trauma. 2001 May;15(4):271-4. doi: 10.1097/00005131-200105000-00006.
- Background: PubMed 23749433Hung M, Baumhauer JF, Latt LD, Saltzman CL, SooHoo NF, Hunt KJ; National Orthopaedic Foot & Ankle Outcomes Research Network. Validation of PROMIS (R) Physical Function computerized adaptive tests for orthopaedic foot and ankle outcome research. Clin Orthop Relat Res. 2013 Nov;471(11):3466-74. doi: 10.1007/s11999-013-3097-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Amanatullah, MD study director
Stanford University School of Medicine, CA
Micheal Weaver, MD principal investigator
Brigham and Women's Hospital, Harvard Medical School, Boston, MA
Domingo Hallare, MD principal investigator
Kaiser Permanente Hospital, South Sacramento, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixation by Acutrak headless screw and Fixation by headed screws, plates, and or wires in people with Medial Malleolus Fractures, run by Stanford University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Severity of Hardware Related Pain Localized to the Medial Malleolus at One Year After Sustaining an Ankle Fracture. (time frame: Baseline, year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061279, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.