- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00816998
Range of Motion and Patients With Distal Radius Fractures
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Minnesota
-
Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: Early
Participants randomized to this arm will begin physical therapy of their fractured wrist approximately one week following surgery
|
Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture
|
Altro: 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.
|
Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Range of motion measurements
Lasso di tempo: at each study visit
|
at each study visit
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Pinch strength
Lasso di tempo: at each study visit
|
at each study visit
|
Grip strength
Lasso di tempo: at each study visit
|
at each study visit
|
Pain
Lasso di tempo: at each study visit
|
at each study visit
|
Return to work
Lasso di tempo: at each study visit
|
at each study visit
|
Scores of DASH & PRWE questionnaires
Lasso di tempo: at each study visit
|
at each study visit
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Alexander Y. Shin, M.D., Mayo Clinic
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 06-004364
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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