Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04847115
Other study ID # 201144
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05450107 - Fifth Metatarsal Orthopedic Outcome Trial N/A
Completed NCT03504462 - Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery N/A
Recruiting NCT02050698 - Hard-soled Shoe Versus Short Leg Walking Cast for a Fifth Metatarsal Avulsion Fracture: A Randomized Multicenter Noninferiority Trial N/A
Completed NCT04168411 - Comparison Different Method Treatment in Tuberosity Fractures of the Proximal Fifth Metatarsal N/A