Comparing Function, Pain and Return to Work in Conservative Versus Surgical Treated Stable Lateral Malleolar Fractures

NCT03587571 | Terminated Phase 4 DMC

• 1 other identifier: 2017-01041
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Ankle fractures are one of the most common fractures in adults resulting in hospital stays and inability to work. Instable or dislocated ankle fractures are mostly treated by surgery. Treatment of stable lateral ankle fractures is still discussed controversial. They can be treated conservatively as well as by surgery. Furthermore, optimal aftercare is part of on-going discussion in both groups. Goal of any treatment is a fast, good functional outcome with pain free patients at low overall costs. Long-term results in terms of osteoarthritis should be kept in mind. The investigators seek to compare conservative and operative treatment in stable lateral ankle fractures in a prospective, randomised trial. The hypothesis is that there is no difference between conservative and surgically treated stable lateral malleolar fractures regarding pain, function, and return to the workplace.

Conditions

Malleolus Fracture, Lateral

Outcome Measures

Primary Outcomes (1)

• Olerud-Molander Ankle Score (OMAS)

  The OMAS Score is a patient-reported scale from 0 (totally impaired) to 100 (completely unimpaired) to evaluate subjectively scored function after ankle fracture. It consists of 9 questions: pain (0 to 25), stiffness (0 to 10), swelling (0 to 10), stair climbing (0 to 10), running (0 to 5), jumping (0 to 5), squatting (0 to 5), use of supports (0 to 10), and work/activity level (0 to 20), with higher scores indicating better outcomes

  after 12 weeks

Secondary Outcomes (5)

• The Visual Analogue Scale Foot and Ankle (VAS FA)

  at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years

• American Orthopedic Foot and Ankle Society Score (AOFAS)

  at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years

• Foot Function Index (FFI)

  at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years

• Return to work

  at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years

• Kellgren-Lawrence scale

  at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years

Study Arms (2)

Surgical intervention

ACTIVE COMPARATOR

Open reduction and osteosynthesis by plating is done. Further after treatment is similar to conservative treatment arm.

Procedure: Surgical intervention

Conservative treatment

NO INTERVENTION

At the first visit a split cast is applied. Afterwards physiotherapy and weightbearing as tolerated is allowed.

Interventions

Surgical intervention PROCEDURE

Open reduction and plate osteosynthesis.

Surgical intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Acute, stable lateral malleolar fracture
• Definition of stable:
• Less than 2mm dislocation in a.p., lateral and gravity-stress x-ray
• Medial tibiotalar distance \<4mm and difference \<1mm compared to the superior clear space on the gravity-stress and weight bearing x-ray
• No talar subluxation
• No intraoperative instability (Hook-/Frick-Test)
• Between 18 and 65 years old
• Living in Switzerland
• Working
• Cognitive and physic ability to follow the study protocol

You may not qualify if:

• Instable fractures
• Previous ipsilateral surgery on the ankle or foot
• Pregnancy
• Diabetes mellitus
• Neurologic or vascular impairment
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Previous enrolment into the current study
• Enrolment of the investigator, his/her family members, employees and other dependent persons

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Inselspital, BERNE

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Ankle Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Fabian Krause, PD Dr.

  Dep. of Orthopaedic Surgery, Inselspital, University of Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of two established treatment options. Prospective, randomised (central block randomisation) multi-center clinical trial. The two treatment options (operative versus conservative) are split in two study arms and compared to each other. Patients are randomly allocated to one of the two study arms.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 16, 2018
• Study Start: May 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

CH (1)