Treatment of Fifth Metatarsal Zone 3 Fractures

Metatarsal Fracture Clinical Trial

Official title:

Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04847115
• Other study ID #: 201144
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: March 31, 2030

Study information

• Verified date: April 2024
• Source: Ostfold Hospital Trust
• Contact: Marius Molund, PhD
• Phone: 0047 90093988
• Email: marius.molund[@]so-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The fifth metatarsal is one of the bones where stress fractures can occur. Current literature provides support for both operative and non-operative treatment, but is mostly based on retrospective studies. One small randomized controlled trial reported faster recovery in the surgery group, but this study is probably subject to selection bias as well as underpowered design. There is a need to strengthen the knowledge base regarding treatment of stress fractures in the fifth metatarsal. This study seeks to answer whether osteosynthesis with an intramedullar screw fixation gives faster painfree weight bearing compared to non-operative treatment with a walking boot.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2030
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Zone 3 fracture

Exclusion Criteria:

• Neuropathy
• Open fractures
• High energy injuries
• Associated injury in the same or opposite extremity that may affect treatment or rehabilitation
• Pressure ulcer(s)
• Lack of consent competence
• Fracture radiologically confirmed more than six months ago
• No possibility of follow-up at one of the study centers
• Established pseudarthrosis
• Medical condition that contraindicates surgery
• Non-compliance

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Stress
• Metatarsal Fracture

Intervention

Procedure:
• Operative
Intramedullary screw fixation

Other:
• Walking boot orthosis
Non-operative treatment with walking boot orthosis for six weeks. The non-operative study arm will use walking boot orthosis only. The operative study arm will use walking boot orthosis as adjuvant treatment.

Locations

Country	Name	City	State
Norway	Østfold Hospital Trust	Grålum
Norway	Akershus University Hospital	Lørenskog
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	Oslo University Hospital, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain free weight bearing	Defined as Visual Analoge Scale below 3. The scale range is 0 to 10, where 0 means "no pain" and 10 means "worst pain".	2 years
Secondary	Palpatory pain	Visual Analog Scale below 3	2 years
Secondary	Radiological healing	Time to radiological callus formation	2 years
Secondary	Work status	Time of sick leave	2 years
Secondary	Refracture	Rate of refractures	2 years
Secondary	Delayed union	Rate of delayed unions	2 years
Secondary	Nonunions	Rate of nonunions	2 years
Secondary	Level of activity	Time to normal activity level is resumed	2 years