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

NCT ID: NCT04615650

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-28
• Study Completion Date: 2025-06-30

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.

Detailed Description

Suprasyndesmotic fractures (Weber type C) are historically treated operatively because of the assumption that the distal tibiofibular syndesmosis is ruptured, leading to joint instability (Lauge-Hansen 1950, Boden 1989).

However, the medial deltoid ligament may function as the main stabiliser of the ankle joint by preventing external rotation of the talus and therefore maintains the dynamic congruity (Michelson 2007). Due to the stabilising effect of the deltoid ligament, an increasing number of transsyndesmotic fractures (Weber type B) are treated non-operatively with excellent results and without the burden of complications that accompany surgery (Gougoulias 2017, Mittal 2017, Bauer 1985).

The aims of the present study are to test the stability of suprasyndesmotic ankle fractures on weight-bearing radiographs and to evaluate the effect of non-operative versus operative treatment of stable suprasyndesmotic fractures.

The patients will have a weight-bearing (at least 50% of body weight) standing radiograph for the evaluation of the stability of the fracture. Patients with a congruent ankle mortise (i.e., stable fracture) on weight-bearing radiographs will be randomised to either operative (ORIF, reference treatment) or non-operative treatment (cast). Patients in both groups are allowed full weight-bearing.

Patients with an incongruent ankle mortise (i.e., unstable fracture) will be treated operatively according to current clinical practice and included in a parallel observational cohort study. Patients who are unwilling to participate in the intervention study are also invited to participate in the observational cohort study.

Conditions

Ankle Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgical treatment

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.

Group Type: ACTIVE_COMPARATOR

Surgical treatment

Intervention Type: PROCEDURE

Surgical treatment of suprasyndesmotic ankle fractures

Non-surgical treatment

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.

Group Type: EXPERIMENTAL

Ankle orthosis

Intervention Type: DEVICE

Non-surgical treatment of suprasyndesmotic ankle fractures

Interventions

Surgical treatment

Surgical treatment of suprasyndesmotic ankle fractures

Intervention Type: PROCEDURE

Ankle orthosis

Non-surgical treatment of suprasyndesmotic ankle fractures

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role: collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Håvard Furunes, PhD

Role: PRINCIPAL_INVESTIGATOR

Sykehuset Innlandet HF

Locations

Vestre Viken Hospital Trust

Bærums verk, Akershus, Norway

Østfold Hospital Trust

Fredrikstad, Akershus, Norway

Sykehuset Innlandet HF

Gjøvik, Innlandet, Norway

Oslo University Hospital

Oslo, Oslo County, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 38191245 (View on PubMed)

Other Identifiers

169307

Identifier Type: -

Identifier Source: org_study_id