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A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01241916
First received: November 15, 2010
Last updated: May 30, 2012
Last verified: May 2012
Results First Received: April 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Post-traumatic Stiff Elbows
Interventions: Device: Static-Progressive Splint
Device: Dynamic Splint

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Static-progressive Splint Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
Dynamic Splint Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.

Participant Flow:   Overall Study
    Static-progressive Splint     Dynamic Splint  
STARTED     35     31  
COMPLETED     28     21  
NOT COMPLETED     7     10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Static-progressive Splint Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
Dynamic Splint Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
Total Total of all reporting groups

Baseline Measures
    Static-progressive Splint     Dynamic Splint     Total  
Number of Participants  
[units: participants]
  35     31     66  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     34     30     64  
>=65 years     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation
  43  ± 13     45  ± 12     44  ± 12  
Gender  
[units: participants]
     
Female     13     13     26  
Male     22     18     40  
Region of Enrollment  
[units: participants]
     
United States     35     31     66  



  Outcome Measures
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1.  Primary:   Change in Arc of Flexion and Extension   [ Time Frame: baseline and 6 months ]

2.  Secondary:   Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Evaluation of <80% of enrolled patients at planned follow-up times; musculoskeletal injury patients are difficult to maintain in protocol. Some violations where enrollment/evaluation points were slightly outside the planned range of acceptable times.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. David Ring
Organization: Massachusetts General Hospital
phone: 617-724-3953
e-mail: dring@partners.org


No publications provided


Responsible Party: David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01241916     History of Changes
Other Study ID Numbers: 2003P001441
Study First Received: November 15, 2010
Results First Received: April 16, 2012
Last Updated: May 30, 2012
Health Authority: USA: Institutional Review Board