Long-Term Outcomes after Surgical Treatment for Foot Injuries - A Multicenter Prospective Cohort Study

Traumatic Foot Injury Collaboration - A Multicenter Prospective Cohort Study for Long-Term Outcomes after Surgical Treatment for Foot Injuries

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29244

Enrollment

200

Registered

2018-12-12

Start date

2019-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Fractures

Interventions

Surgical treatment for (posttraumatic sequelae of) foot injuries.

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must be undergoing operative treatment for at least one (posttraumatic sequelae of a) traumatic foot fracture and/or dislocation at one of the participating centers. All subjects must be at least 18 years of age at the time of surgery.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Initial surgical treatment elsewhere (in case of an acute injury) - Initial trauma >6 weeks before presentation (in case of an acute injury) - Pathological/non-traumatic fractures - Residency abroad - No Dutch proficiency - Mental impairment

Design outcomes

Primary

Measure	Time frame
Health-related quality of life as measured using the EQ-5D-3L	—

Secondary

Measure	Time frame
- Functional outcome as measured using the AOFAS Forefoot, Midfoot, and/or Ankle-Hindfoot scale - Return to work - Return to sports - Complication after surgery; deep infection, superficial infection, wound healing disorder, thromboembolic complication, implant failure, re-fracture and/or other - Need for secondary surgery (with indication, also if performed at outside facility) - Implant removal; yes or no and reason if positive - Transfer (L2 to L1 and vice versa) - Surgical team composition (surgeon(s) from hosting facility only, combination of surgeons)	—

Measure

Time frame

- Functional outcome as measured using the AOFAS Forefoot, Midfoot, and/or Ankle-Hindfoot scale - Return to work - Return to sports - Complication after surgery; deep infection, superficial infection, wound healing disorder, thromboembolic complication, implant failure, re-fracture and/or other - Need for secondary surgery (with indication, also if performed at outside facility) - Implant removal; yes or no and reason if positive - Transfer (L2 to L1 and vice versa) - Surgical team composition (surgeon(s) from hosting facility only, combination of surgeons)

—

Contacts

Public ContactR.M. Houwert

University Medical Center Utrecht

088 755 5555

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)