RCT Comparing Non-operative vs Operative Treatment of Suprasyndesmotic Ankle Fractures.

NCT04615650 | Active Not Recruiting

• 1 other identifier: 169307
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

Weight-bearing radiographs will be used to evaluate the stability of suprasyndesmotic ankle fractures. Patients with stable fractures will be randomised to operative or non-operative treatment.

Conditions

Ankle Fractures

Keywords

ankle fractures; surgical treatment; conservative treatment; weight-bearing

Outcome Measures

Primary Outcomes (1)

• Olerud-Molander Ankle Score (OMAS)

  The primary outcome measure is the Olerud-Molander Ankle Score (OMAS), which is a condition-specific, patient-reported measure of ankle-fracture symptoms. OMAS ranges from 0 to 100, with higher scores indicating better outcomes and fewer symptoms.

  The main statistical analysis of the primary outcome will be based on the two-year follow-up.

Secondary Outcomes (6)

• Ankle pain

  The main statistical analysis of the outcome will be based on the two-year follow-up.

• Manchester-Oxford Foot Questionnaire (MOxFQ)

  The main statistical analysis of the outcome will be based on the two-year follow-up.

• EuroQol questionnaire (EQ-5D)

  The main statistical analysis of the outcome will be based on the two-year follow-up.

• Radiographic results

  The main statistical analysis of the outcome will be based on the two-year follow-up.

• Range of motion

  The main statistical analysis of the outcome will be based on the two-year follow-up.

Study Arms (2)

Surgical treatment

ACTIVE COMPARATOR

Patients randomised to operative treatment will have their surgery performed by an orthopaedic surgeon or by orthopaedic trainees under the supervision of a consultant, when fit for surgery. The surgical technique and choice of implants will be decided by the surgeon in order to closely resemble everyday clinical practice. The syndesmosis must be reduced (closed or open) and fixed. Postoperatively, the patients will be treated with an ankle orthosis for six weeks with weight-bearing as tolerated.

Procedure: Surgical treatment

Non-surgical treatment

EXPERIMENTAL

Patients randomised to non-operative treatment are treated with an ankle orthosis for six weeks with weight-bearing as tolerated. Other types of casts can be used if preferred by the treating orthopaedic surgeon, but the cast must allow full weight-bearing and must prevent equinus position.

Device: Ankle orthosis

Interventions

Surgical treatment PROCEDURE

Surgical treatment of suprasyndesmotic ankle fractures

Surgical treatment

Ankle orthosis DEVICE

Non-surgical treatment of suprasyndesmotic ankle fractures

Non-surgical treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who present with a closed, isolated fibular fracture classified as suprasyndesmotic (Weber C) with a medial clear space of less than 7 mm in mortise view on primary radiographs.
• presentation less than 14 days after the injury.

You may not qualify if:

• previous fractures or ligamentous injury to the injured ankle.
• pathological fracture.
• diabetic neuropathy or other neuropathies.
• drug abuse.
• inability to consent and/or comply.
• inability to understand Norwegian language.
• inability to walk unaided prior to the fracture.
• patients with a concomitant tibial fracture requiring surgical treatment are excluded, but patients with undisplaced concomitant tibial fractures can be included.
• patients from outside the catchment area of the recruiting hospitals. However, they can be included if they are willing to undergo follow-up visits at one of the recruiting hospitals.

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead
• Oslo University Hospital: collaborator
• Vestre Viken Hospital Trust: collaborator
• Ostfold Hospital Trust: collaborator

Study Sites (4)

Vestre Viken Hospital Trust

Bærums verk, Akershus, 1347, Norway

Location

Østfold Hospital Trust

Fredrikstad, Akershus, 1714, Norway

Location

Sykehuset Innlandet HF

Gjøvik, Innlandet, 2819, Norway

Location

Oslo University Hospital

Oslo, Oslo County, 4950, Norway

Location

Related Publications (1)

• Saatvedt O, Riiser M, Frihagen F, Figved W, Madsen JE, Molund M, Furunes H. Non-operative versus operative treatment of suprasyndesmotic ankle fractures: protocol for a prospective, multicentre, randomised controlled trial. BMJ Open. 2024 Jan 8;14(1):e075122. doi: 10.1136/bmjopen-2023-075122.

  PMID: 38191245 DERIVED

MeSH Terms

Conditions

Ankle Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Håvard Furunes, PhD

  Sykehuset Innlandet HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data will be plotted into a database by an independent blinded data manager.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled multicentre trial

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 4, 2020
• Study Start: December 28, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (4)