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NCT03539029: WEBER
Surgical Versus Conservative Treatment of Weber B1 Fracture: Functional Outcome Using Gait Analysis
trial testing Surgery in Ankle Fracture - Lateral Malleolus in 29 participants. Completed in 30 April 2020.
30 April 2020
Quick facts
| Lead sponsor | University Hospital, Basel, Switzerland |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 29 |
| Start date | 1 May 2018 |
| Primary completion | 30 April 2020 |
| Estimated completion | 30 April 2020 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Surgery
- Conservative treatment — full drug profile →
Conditions studied
- Ankle Fracture - Lateral Malleolus — all drugs for Ankle Fracture - Lateral Malleolus →
Sponsor
University Hospital, Basel, Switzerland
Who can join
18 and older, any sex, with Ankle Fracture - Lateral Malleolus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The decision whether to operate an ankle fracture or not is often highly dependent on the surgeon's individual judgment. There is consensus that non-displaced Weber A-type fractures rarely require operative treatment, and that Weber C-type or grossly displaced fractures are unstable and therefore require surgery. The decision for appropriate treatment is less clear for minimally displaced Weber B-type ankle fractures, and especially Weber B1 fractures are treated either surgically or conservatively at our clinic. Conservative management of ankle fractures generally comprises immobilisation in a below-knee VacoPed or cast for six weeks to stabilise the fracture and allow osseous and soft tissue healing. Surgical treatment involves the reduction (if displaced) of the fractured fragments and fixation using various devices such as metal plates, screws, or intramedullary rods. While patients show changes in plantar pressure distribution during gait 18 months after surgical treatment of ankle fractures, to date the functional outcome regarding ankle joint mechanics during daily activities are unknown. Understanding gait function is important because compromised function may not only limit a persons daily activities but also may lead to secondary conditions such as osteoarthritis at the ankle or at adjacent joints. The primary objective is: • To compare differences in hindfoot and forefoot kinematics between level and uphill treadmill walking in relation to passive range of motion The secondary objectives are: * To compare ankle biomechanics during overground walking and level and uphill treadmill walking between patients with Weber B1 fracture treated either surgically or conservatively and healthy control persons. * To determine the relationship between passive ankle range of motion, lower leg muscle strength and dynamic ankle range of motion. * To determine the relationship between lower leg muscle strength and balance. * To determine the relationship between dynamic range of motion and the Foot and Ankle Outcome Score.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03539029
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03539029 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Basel, Switzerland
- Last refreshed: 19 March 2024
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