Range of Motion and Patients With Distal Radius Fractures
6 avril 2011 mis à jour par: Mayo Clinic
The Effect of Early vs. Delayed Range of Motion in the Outcome of Patients With Distal Radius Fractures
Hypothesis : Early active range of motion protocol after open reduction and internal fixation of a distal radius fracture with a volar fixed angle locking plate results in earlier return of functional motion, earlier return to work and improved functional outcomes compared delayed mobilization.
Specific Aim:
To compare early range of motion versus delayed motion protocol in distal radius fractures treated with open reduction and internal fixation with a volar fixed angle locking plate with respect to time to fracture union, range of motion, functional outcome measures, return to work and complications.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
You are scheduled for surgery of your broken wrist.
Treatment of broken bones of the wrist, such as distal radius fractures, may require different types of treatment.
For this study this type of fracture will be treated by surgery to place a plate with screws to the broken bone and then a plaster splint will be applied.
After surgery, physical therapy will be started.
Following surgery you will be assigned to one of four groups by the type of wrist fracture (broken bone) you have.
Each person will by chance (the flip of a coin) be put in either the Early or Delayed Range of Motion groups.
Those in the Early Range of Motion groups will begin exercises for motion starting 7 days after surgery.
Those in the Delayed Range of Motion, will begin exercises for motion starting about five weeks after surgery.
Once you begin the exercises to help you get back normal use of your wrist, you will have measurements of how much motion and strength you have in the wrist and hand that was fractured.
The measurements will take about five minutes to complete.
All participants will have an x-ray of the wrist at 2, & 6 weeks following surgery and if needed at other appointments.
At each appointment you will be asked to fill out four questionnaires, asking about pain and how you are getting along with the broken bone in your wrist.
The questionnaires will take about 20 minutes of your time to complete.
At Week 26 you will be asked to record the amount of motion you have in both of your wrists on paper drawings as well as the measurements that we will make.
Working with the drawings will take approximately five minutes.
At Week 52 you will be asked two questions about how satisfied you are with the results of your surgery.
Surgery, x-ray of your wrist, and exercise to help you get back motion of your broken wrist are all standard orthopedic practice for treating a broken wrist bone.
Type d'étude
Interventionnel
Inscription (Réel)
39
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
The following criteria must be met to be enrolled:
- Have a closed unstable distal radius fracture
- Have a fracture classified as an AO Type A or C fracture, with or without an ulnar styloid fracture
- Be a male or non-pregnant female at least 18 years of age.
- Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol
- Have the ability to understand and provide written authorization for use and disclosure of personal health information
Exclusion Criteria:
Participants are excluded if they:
Have any of the following conditions
- Concomitant contralateral or ipsilateral upper extremity fractures
- Ipsilateral ulna (excluding styloid) fracture
- Open, multi-fragmentary fracture
- Artery or Nerve injury secondary to fracture
- Have had a previous ipsilateral distal radius fracture in the 2 years prior to enrollment
- Are currently on chemotherapy or radiation therapy
- A history of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
- A history of uncontrolled diabetes
- Are unable to provide consent for the study
- Are unable to make the follow-up appointments required of the study
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
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 |
|---|---|
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Autre: Early
Participants randomized to this arm will begin physical therapy of their fractured wrist approximately one week following surgery
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Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture
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Autre: Delayed
Participants randomized to this group will begin physical therapy of their fractured wrist approximately 6 weeks from their surgery.
This is the approximate time frame in which therapy begins for patients not involved in the study.
The term Delayed refers to therapy being delayed in starting from those in the study who begin therapy at one week post-operatively, not a delay in current care practice.
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Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Range of motion measurements
Délai: at each study visit
|
at each study visit
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Pinch strength
Délai: at each study visit
|
at each study visit
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Grip strength
Délai: at each study visit
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at each study visit
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Pain
Délai: at each study visit
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at each study visit
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Return to work
Délai: at each study visit
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at each study visit
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Scores of DASH & PRWE questionnaires
Délai: at each study visit
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at each study visit
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Alexander Y. Shin, M.D., Mayo Clinic
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2006
Achèvement primaire (Réel)
1 février 2010
Achèvement de l'étude (Réel)
1 février 2010
Dates d'inscription aux études
Première soumission
5 janvier 2009
Première soumission répondant aux critères de contrôle qualité
5 janvier 2009
Première publication (Estimation)
6 janvier 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
8 avril 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 avril 2011
Dernière vérification
1 avril 2011
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 06-004364
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 .