Evaluating non-operative treatment for stable bi- and trimalleolar ankle fractures
Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures
NA · Ostfold Hospital Trust · NCT05765929
This study is testing if non-surgical treatment can effectively help adults with stable ankle fractures heal without needing surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ostfold Hospital Trust (other) |
| Locations | 1 site (Sarpsborg, Østfold fylke) |
| Trial ID | NCT05765929 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the outcomes of non-operative treatment for patients with stable bi- and trimalleolar ankle fractures, specifically those with less than 7 mm medial clear space on non-weightbearing radiographs. Participants will be evaluated for stability using weightbearing radiographs within 14 days of injury. The focus is on understanding how effective non-surgical management can be for these types of fractures, which are common yet complex injuries. The study will involve patients aged 18 to 75 who had no prior walking aids before their injury.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with stable bi- or trimalleolar ankle fractures and no prior walking disabilities.
Not a fit: Patients with unstable ankle fractures or those requiring surgical intervention will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option for patients with specific types of ankle fractures, potentially reducing the need for surgery.
How similar studies have performed: While there is limited information on similar studies, the approach of evaluating non-operative treatment for stable fractures has shown promise in other orthopedic contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * -With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs. * With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici classification). (6) * With fractures in the distal 1/3 of fibula (not-Maisonneuve) * Enabling stability evaluation within 14 days after injury * 18-75 years of age * with pre-injury walking ability without aids Exclusion Criteria: * \- With primary unstable ankle fractures, \> 7mm medial clear space on primary radiographs * With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture * With type A medial malleolus avulsion fractures \< 5mm (at the tip of the malleolus), that are not suitable for surgical intervention. * With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond) * With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon * With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis * That are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders) * With previous history ipsilateral ankle fracture * With previous history ipsilateral major ankle-/foot surgery * Who live outside the hospital catchment areas not available to follow up * With insufficient Norwegian or English language skills * Non-compliant
Where this trial is running
Sarpsborg, Østfold fylke
- Østfold Hospital Trust — Sarpsborg, Østfold fylke, Norway (RECRUITING)
Study contacts
- Study coordinator: Marius Molund, PhD
- Email: mariusmolund@hotmail.com
- Phone: 0047 90093988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar