Permissive weight bearing in trauma patients with fracture of the lower extremities

Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multi-center trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27998

Enrollment

120

Registered

2016-09-01

Start date

2017-01-01

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

Trauma, permissive weight bearing, rehabilitation, fractures of the lower extremitiets.

Interventions

Permissive weight bearing group: Treatment according to the PROMETHEUS protocol (treatment- and evaluation protocol), patients will have an optimal/intensive weight bearing treatment. The protocol con

Eligibility

Inclusion criteria

Inclusion criteria: • Trauma patients with surgically treated fractures of the lower extremities • Age > 18 • No additional problem of rheumatic orthopaedic or neurological nature of the lower extremities (i.e. primary coxarthrosis or gonarthrosis) • Being able to understand the questionnaires and measurement instructions

Exclusion criteria

Exclusion criteria: • Amputation patients (Upper limb, lower limb, feet) and bilateral fractures of the lower extremities. • Severe non fracture related comorbidity of the lower extremity • No informed consent • Additional complaints who influence the measurements

Design outcomes

Primary

Measure	Time frame
Main outcome variable: -ADL (LEFS) with LEFS Outcome variables for functional outcome: -Score on LEFS at 0,1, 3, 6, 12, and 26 weeks post-surgery LEFS: is a questionnaire containing 20 questions about a person’s ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. The questionnaire consist of 80 points. The lower the score the greater the disability.	—

Measure

Time frame

Main outcome variable: -ADL (LEFS) with LEFS Outcome variables for functional outcome: -Score on LEFS at 0,1, 3, 6, 12, and 26 weeks post-surgery LEFS: is a questionnaire containing 20 questions about a person’s ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. The questionnaire consist of 80 points. The lower the score the greater the disability.

—

Secondary

Measure	Time frame
Secondary outcome variables: - Function (Brunnstorm Fugl-Meyer) - Participation (SF-36) - Reduction in health and society costs - Improvement in quality of life - Composite end-point: total complication rate Outcome variables for functional outcome: - Score on Brunnstrom Fugl-Meyer at 0,1, 3, 6, 12, and 26 weeks post-surgery - Score on SF-36 at 0,1, 3, 6, 12, and 26 weeks post-surgery - Score on EQ-5D-5L at 0,1, 3, 6, 12, and 26 weeks post-surgery Brunnstrom Fugl-Meyer: is a test that evaluate the degree of synergy formation. The test consists of 55 test items that can be scored at an ordinal 3 - point scale (0-2 points). The total test consists of an examination of the upper extremity , an examination of the lower extremity and an examination of the balance. For our study we want to use only the examination of the lower extremity. The total score for the motion of the lower extremities consist of 34 points. SF-36: is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The higher the score the better the participation. EuroQol: The primary outcome measure for the cost-effectiveness analysis will be better in functional outcome during 6 months of follow-up. Within the cost-utility analysis, outcomes will be measured by means of the standard Dutch version of the EuroQol. This is a self-administered questionnaire, which will be completed at baseline together with the cost questionnaire at the same moments (0,1,3,6,12,26). Both generic quality of life, as well as utilities, will be derived by means of the EQ-5D, which will be administered both by the patients. The EQ-5D is chosen because it is a widely used quality of life instrument (nationally and internationally) and it is recommended by the Dutch guidelines. The EQ-5D contains 5 dimensions of h	—

Measure

Time frame

Secondary outcome variables: - Function (Brunnstorm Fugl-Meyer) - Participation (SF-36) - Reduction in health and society costs - Improvement in quality of life - Composite end-point: total complication rate Outcome variables for functional outcome: - Score on Brunnstrom Fugl-Meyer at 0,1, 3, 6, 12, and 26 weeks post-surgery - Score on SF-36 at 0,1, 3, 6, 12, and 26 weeks post-surgery - Score on EQ-5D-5L at 0,1, 3, 6, 12, and 26 weeks post-surgery Brunnstrom Fugl-Meyer: is a test that evaluate the degree of synergy formation. The test consists of 55 test items that can be scored at an ordinal 3 - point scale (0-2 points). The total test consists of an examination of the upper extremity , an examination of the lower extremity and an examination of the balance. For our study we want to use only the examination of the lower extremity. The total score for the motion of the lower extremities consist of 34 points. SF-36: is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The higher the score the better the participation. EuroQol: The primary outcome measure for the cost-effectiveness analysis will be better in functional outcome during 6 months of follow-up. Within the cost-utility analysis, outcomes will be measured by means of the standard Dutch version of the EuroQol. This is a self-administered questionnaire, which will be completed at baseline together with the cost questionnaire at the same moments (0,1,3,6,12,26). Both generic quality of life, as well as utilities, will be derived by means of the EQ-5D, which will be administered both by the patients. The EQ-5D is chosen because it is a widely used quality of life instrument (nationally and internationally) and it is recommended by the Dutch guidelines. The EQ-5D contains 5 dimensions of h

—

Contacts

Public ContactPishtiwan Kalmet

Maastricht universitair medisch centrum - Afd. Traumatologie

pishtiwan.kalmet@mumc.nl06-27020227

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)