Mobilisation immédiate versus immobilisation plâtrée de 2 semaines après une fracture du radius distal traitée avec une plaque de verrouillage palmaire (LIMPER-DRF)
Mobilisation immédiate versus immobilisation plâtrée de 2 semaines après une fracture du radius distal traitée avec une plaque de verrouillage palmaire - un protocole d'étude pour un essai prospectif, randomisé et contrôlé
The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Intra- or extra articular DRF (Colles, Smith, Volar barton)
- operative treatment justified
Exclusion Criteria:
- Refusal to participate in the study
- Open fracture with a severity greater than Gustilo grade 1
- Patient aged less than 18 or over 65
- Patient does not understand written or spoken guidance in local languages
- Pathological fracture
- Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
- Ipsilateral fracture in upper extremity
- Associated fractures of the ulna (except fractures of the PSU)
- Polytrauma
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Mobilisation immédiate après fracture distale du radius traitée avec plaque de verrouillage palmaire
|
Immediate mobilization postoperatively without casting Volar plating of distal radius fracture |
|
Comparateur actif: 2 semaines d'immobilisation plâtrée après une fracture distale du radius traitée avec une plaque de verrouillage palmaire
|
Volar plating of distal radius fracture Dorsal cast placed in OR |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient-rated wrist evaluation questionnaire
Délai: 2 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
2 months
|
|
Total lenght of the sick leave
Délai: 12 months
|
Total number of days of work during the 1 year study period |
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient-rated wrist evaluation questionnaire
Délai: 4 weeks
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
4 weeks
|
|
Patient-rated wrist evaluation questionnaire
Délai: 6 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
6 months
|
|
Patient-rated wrist evaluation questionnaire
Délai: 12 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
12 months
|
|
Return to work
Délai: 4 weeks
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
4 weeks
|
|
Return to work
Délai: 2 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
2 months
|
|
Return to work
Délai: 6 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
6 months
|
|
Return to work
Délai: 12 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
12 months
|
|
Complications
Délai: 4 weeks
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
4 weeks
|
|
Complications
Délai: 2 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
2 months
|
|
Complications
Délai: 6 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
6 months
|
|
Complications
Délai: 12 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
12 months
|
|
Self-perceived working ability
Délai: 4 weeks
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
4 weeks
|
|
Self-perceived working ability
Délai: 2 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
2 months
|
|
Self-perceived working ability
Délai: 6 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
6 months
|
|
Self-perceived working ability
Délai: 12 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
12 months
|
|
Visual analogue pain scale
Délai: 4 weeks
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
4 weeks
|
|
Visual analogue pain scale
Délai: 2 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
2 months
|
|
Visual analogue pain scale
Délai: 6 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
6 months
|
|
Visual analogue pain scale
Délai: 12 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
12 months
|
|
Patient-acceptable symptom state
Délai: 2 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
2 months
|
|
Patient-acceptable symptom state
Délai: 6 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
6 months
|
|
Patient-acceptable symptom state
Délai: 12 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
12 months
|
|
Work capacity
Délai: 4 weeks
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
4 weeks
|
|
Work capacity
Délai: 2 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
2 months
|
|
Work capacity
Délai: 6 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
6 months
|
|
Work capacity
Délai: 12 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
12 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient activity
Délai: 4 weeks
|
Patient activity measured with triaxial wrist accelerometer |
4 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Aleksi Reito, Tampere University Hospital
- Chercheur principal: Laura Kärnä, MD, Tampere University Hospital
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R21111
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Data is available on reasonable request.
Délai de partage IPD
After the study has been completed and for 10 years after.
Critères d'accès au partage IPD
On reasonable request and research plan for IPD use should be provided.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .