Post Operative Treatment After Unstable Malleolar FracturesNCT06023979
Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.
A study testing Full weight bearing and Partial weight bearing in people with Post Operative Treatment After Unstable Malleolar Fractures, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Treatment After Unstable Malleolar Fractures
- What is being tested?
- Full weight bearing and Partial weight bearing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2023to 31 Oct 2026
- 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
- patients with surgically stabilized unstable ankle fractures
- signed informed consent
- closed tibial and fibular epiphysis
- age 18 or older
Who cannot join
- dementia and other known cognitive impairment or incapacity of judgement
- polytrauma
- bilateral injury of the lower extremities
- additional injury of the ipsilateral lower extremity which prevents full weight bearing
- associated injury of one or both upper extremities
- open fractures grade II° and III°
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- chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy
- open epiphysis
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Canton Hospital St. Gallen
Sankt Gallen, 9007
Primoz Potocnik, MD, primoz.potocnik@kssg.ch
Andreas Toepfer, MD, andreas.toepfer@kssg.ch
About this study
Official title: Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles. A Single Blinded Randomized Controlled Study
The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.
Read the detailed description
This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.
- Being tested
- Full weight bearing, Partial weight bearing
- Keywords
- malleolar fractures, postoperative treatment protocol, full weight bearing, partial weight bearing, bio-feedback insoles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full weight bearingOther
Full weight bearing monitored with a bio-feedback insole
Partial weight bearingOther
Partial weight bearing monitored with a bio-feedback insole
| Study group | Role | What they receive |
|---|---|---|
| Full weight bearing | Experimental | After 2 weeks after surgery the arm will begin full weight bearing Receives: Other: Full weight bearing |
| Partial weight bearing | Active comparator | The arm will perform partial weight bearing for 6 weeks after surgery Receives: Other: Partial weight bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manchester Oxford Foot and Ankle Questionnaire
Patient reported Outcome measure
Measured: 1 year
Secondary outcomes (3)
other PROMs (patient reported outcome measures)
Measured: 1 year
Range of Motion
Measured: 1 year
Secondary dislocation of fracture
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Treatment After Unstable Malleolar FracturesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Primoz Potocnik, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023979
- Sponsor's protocol ID
- BASEC Nr. 2023-01242
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles. A Single Blinded Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06023979
- Acronym / sponsor ID
- BASEC Nr. 2023-01242
- Keywords
- malleolar fractures, postoperative treatment protocol, full weight bearing, partial weight bearing, bio-feedback insoles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 5 Sep 2023 (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.
The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.
Detailed description
This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full weight bearing | Experimental | Other: Full weight bearingAfter 2 weeks after surgery the arm will begin full weight bearing |
| Partial weight bearing | Active comparator | Other: Partial weight bearingThe arm will perform partial weight bearing for 6 weeks after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with surgically stabilized unstable ankle fractures
- signed informed consent
- closed tibial and fibular epiphysis
- age 18 or older
Key exclusion criteria (9 listed)
- dementia and other known cognitive impairment or incapacity of judgement
- polytrauma
- bilateral injury of the lower extremities
- additional injury of the ipsilateral lower extremity which prevents full weight bearing
- associated injury of one or both upper extremities
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 |
|---|---|---|
| Full weight bearingFull weight bearing monitored with a bio-feedback insole | Other | Full weight bearing |
| Partial weight bearingPartial weight bearing monitored with a bio-feedback insole | Other | Partial weight bearing |
Primary outcome
Manchester Oxford Foot and Ankle Questionnaire
Time frame: 1 year
Patient reported Outcome measure
3 secondary outcomes
other PROMs (patient reported outcome measures)
Time frame: 1 year
Range of Motion
Time frame: 1 year
Secondary dislocation of fracture
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full weight bearing and Partial weight bearing in people with Post Operative Treatment After Unstable Malleolar Fractures, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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 4 inclusion and 9 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 5 Sep 2023. 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 Switzerland. 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?
Contact Primoz Potocnik, MD (0041714941111, primoz.potocnik@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manchester Oxford Foot and Ankle Questionnaire (time frame: 1 year). 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 5 Sep 2023.