Surgical Versus Conservative Treatment of Weber B1 Fracture: Functional Outcome Using Gait Analysis

NCT03539029 | Completed

• 1 other identifier: 2018-00513
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Fracture - Lateral Malleolus

Outcome Measures

Primary Outcomes (1)

• 3D hindfoot and forefoot range of motion during level and uphill walking

  assessed in degrees as max plantarflexion to max dorsiflexion of the ankle using marker and camera based motion capture

  Baseline

Secondary Outcomes (8)

• single leg balance

  Baseline

• ankle power

  Baseline

• Isokinetic strength in plantarflexion, dorsiflexion, inversion, and eversion

  Baseline

• Lower leg muscle activation

  Baseline

• clinical outcome

  Baseline

Study Arms (3)

Control group

age and sex matched healthy control persons

Surgery

patients with ankle fracture treated surgically

Procedure: Surgery

Conservative treatment

patients with ankle fracture treated conservatively

Procedure: Conservative treatment

Interventions

Surgery PROCEDURE

Surgical fracture fixation

Surgery

Conservative treatment PROCEDURE

immobilisation with plaster cast

Conservative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 patients with Weber B1 treated surgically; 20 patients with Weber B1 treated conservatively; 20 age and sex matched healthy control persons

You may qualify if:

• Age ≥ 18 years
• Surgical or conservative treatment after lateral malleolar fracture
• ≥12 months follow-up

You may not qualify if:

• Neuromuscular disorders affecting gait
• Additional pathologies that influence the mobility of the ankle joint
• Bilateral trauma at presentation
• Persistent use of walking aids
• Inability to provide informed consent

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Ankle Fractures

Interventions

Surgical Procedures, Operative; Conservative Treatment

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Annegret Mündermann, PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 29, 2018
• Study Start: May 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CH (1)