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

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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 ]

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2. Secondary:

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

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	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.

Serious Adverse Events

	Static-progressive Splint	Dynamic Splint
Total, serious adverse events
# participants affected / at risk	0/35 (0.00%)	0/31 (0.00%)

Other Adverse Events

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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.

Limitations and Caveats

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.

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

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