Fibula FractureNCT04872296
Weight Bearing for Fibular Fractures
A study testing Physical Therapy in people with Fibula Fracture, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
It is common practice to restrict weight bearing after ankle fracture open reduction and internal fixation (ORIF) until week 6 postoperatively. However, controversy exists surrounding the optimal postoperative protocol. At our institution, all ankle fractures are made non-weight bearing for 6 weeks across the board. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibula Fracture
- What is being tested?
- Physical Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2018to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (age>18) undergoing surgical treatment for isolated lateral malleolar fracture with foot and ankle surgeons at the Rothman Orthopaedic Institute
Who cannot join
- Patients requiring other fracture fixation, deltoid ligament repair, or syndesmosis fixation
- Revision ankle fracture cases
- Pre-existing impaired mobility,
- Pre-existing cognitive disability,
- Open fractures,
- BMI >40,
- Diabetes mellitus (DM)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Early Weight Bearing for Isolated Fibular Fractures: A Prospective Randomized Study
It is common practice to restrict weight bearing after ankle fracture open reduction and internal fixation (ORIF) until week 6 postoperatively. However, controversy exists surrounding the optimal postoperative protocol. At our institution, all ankle fractures are made non-weight bearing for 6 weeks across the board. Isolated lateral malleolar fractures after ORIF may benefit from earlier weight bearing in terms of patient satisfaction, short-term functionality, and return to work. The purpose of this study is to determine if early weight bearing at 2 weeks postoperatively for isolated lateral malleolar fractures leads to a higher satisfaction with surgery as compared to standard protocol for postoperative ankle fractures and better functional outcomes
- Conditions
- Fibula Fracture
- Being tested
- Controlled Ankle Motion (CAM) boot, Physical Therapy
- Medical subject headings
- Fibula Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Ankle Motion (CAM) bootDevice
A CAM boot will be worn on the affected ankle to allow weight bearing
Physical TherapyProcedure or surgery
Standard physical therapy protocol will be started at 6 weeks after surgery
| Study group | Role | What they receive |
|---|---|---|
| Early weight bearing | Active comparator | Participants treated for an ankle fracture will be allowed to weight bear early after surgery starting at 2 weeks post operatively Receives: Device: Controlled Ankle Motion (CAM) boot; Procedure: Physical Therapy |
| Postponed weight bearing | Active comparator | Participants treated for an ankle fracture will be treated with standard protocol of non-weight bearing for 6 weeks post operatively. Receives: Device: Controlled Ankle Motion (CAM) boot; Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Satisfaction with treatment #1
Participant satisfaction will be measured using the Short Form-12 survey (SF-12)
Measured: 24 weeks
Participant Satisfaction with treatment #2
Participant satisfaction will be measured using the Foot and Ankle Ability Measure (FAAM) scores
Measured: 24 weeks
Participant Pain after surgery
Participant Pain will be measured using the Visual Analog Scale for Pain (VAS) score
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start20 Dec 2018
- Primary completion20 Dec 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibula FractureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872296
- Sponsor's protocol ID
- RSHA18D.798
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weight Bearing for Isolated Fibular Fractures: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04872296
- Acronym / sponsor ID
- RSHA18D.798
- Conditions
- Fibula Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is common practice to restrict weight bearing after ankle fracture open reduction and internal fixation (ORIF) until week 6 postoperatively. However, controversy exists surrounding the optimal postoperative protocol. At our institution, all ankle fractures are made non-weight bearing for 6 weeks across the board. Isolated lateral malleolar fractures after ORIF may benefit from earlier weight bearing in terms of patient satisfaction, short-term functionality, and return to work. The purpose of this study is to determine if early weight bearing at 2 weeks postoperatively for isolated lateral malleolar fractures leads to a higher satisfaction with surgery as compared to standard protocol for postoperative ankle fractures and better functional outcomes
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early weight bearing | Active comparator | Device: Controlled Ankle Motion (CAM) boot, Procedure: Physical TherapyParticipants treated for an ankle fracture will be allowed to weight bear early after surgery starting at 2 weeks post operatively |
| Postponed weight bearing | Active comparator | Device: Controlled Ankle Motion (CAM) boot, Procedure: Physical TherapyParticipants treated for an ankle fracture will be treated with standard protocol of non-weight bearing for 6 weeks post operatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (age>18) undergoing surgical treatment for isolated lateral malleolar fracture with foot and ankle surgeons at the Rothman Orthopaedic Institute
Key exclusion criteria (7 listed)
- Patients requiring other fracture fixation, deltoid ligament repair, or syndesmosis fixation
- Revision ankle fracture cases
- Pre-existing impaired mobility,
- Pre-existing cognitive disability,
- Open fractures,
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 |
|---|---|---|
| Controlled Ankle Motion (CAM) bootA CAM boot will be worn on the affected ankle to allow weight bearing | Device | Early weight bearing, Postponed weight bearing |
| Physical TherapyStandard physical therapy protocol will be started at 6 weeks after surgery | Procedure or surgery | Early weight bearing, Postponed weight bearing |
Primary outcome
Participant Satisfaction with treatment #1
Time frame: 24 weeks
Participant satisfaction will be measured using the Short Form-12 survey (SF-12)
Participant Satisfaction with treatment #2
Time frame: 24 weeks
Participant satisfaction will be measured using the Foot and Ankle Ability Measure (FAAM) scores
Participant Pain after surgery
Time frame: 24 weeks
Participant Pain will be measured using the Visual Analog Scale for Pain (VAS) score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Fibula Fracture, run by Rothman Institute Orthopaedics at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Participant Satisfaction with treatment #1 (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2021.