Cervical Spinal Cord InjuryNCT01204736
Comparing Outcomes of Elbow Extension Tendon Transfers
An observational study of Cervical Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Active elbow extension has significant functional benefits for individuals with tetraplegia. The proposed work will provide information to assess how effectively people are using their elbow extension tendon transfers, and whether one surgery works more effectively than the other. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Spinal Cord Injury
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Three groups of subjects will be recruited to participate in the experiments: individuals that have had the posterior deltoid to triceps tendon transfer, individuals that have the biceps to triceps tendon transfer, and individuals with SCI between C5-C7 who have not had tendon transfers. Nominally, we plan to recruit 15 subjects from each group.
Who may be able to join
- Cervical Spinal Cord Injury (C5-C7)
- Posterior Deltoid to Triceps Tendon Transfer at least one year post-surgery
- Biceps to Triceps Tendon Transfer at least one year post-surgery
Who cannot join
- Subjects will be excluded from the studies if there is presence of concurrent severe medical illness, including:
- unhealed decubiti
- use of baclofen pumps
- existing infection
- cardiovascular disease
- significant osteoporosis (as indicated by a history of fractures following injury)
- or a history of pulmonary complications or autonomic dysreflexia
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
About this study
Official title: A Comparison of Two Surgical Procedures That Restore Elbow Extension
Active elbow extension has significant functional benefits for individuals with tetraplegia. The proposed work will provide information to assess how effectively people are using their elbow extension tendon transfers, and whether one surgery works more effectively than the other. This study will provide recommendations to clinicians about the possibility of improving function after surgery using rehab techniques.
Read the detailed description
Voluntary control of elbow extension significantly improves functional abilities for individuals with tetraplegia. As a result, surgical reconstruction of elbow extension via tendon transfer is considered a fundamental intervention that benefits the patient, even if other tendon transfers aimed at improving hand function are never performed. Presently, there are two common tendon transfer surgeries used to restore elbow extension following spinal cord injury. These are the posterior deltoid to triceps transfer and the biceps to triceps transfer. Both surgeries significantly improve voluntary elbow extension, although there is variability in the amount of control that is restored among patients. This study will directly compare the performance of the posterior deltoid transfer to the biceps transfer with regard to: voluntary elbow extension strength, the ability to activate the transfer, and neural factors associated with voluntary and involuntary control of individual muscles. These comparisons will be made in functionally relevant postures and will provide fundamental information that will improve clinical understanding of the capacity of each of these two procedures to restore elbow extension.
The fundamental hypothesis of this proposal is that an inability to maximally activate the transferred posterior deltoid and the transferred biceps significantly limits the elbow extension moment that can be produced.
- Conditions
- Cervical Spinal Cord Injury
- Keywords
- tendon transfer, elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Subjects with posterior deltoid-to-triceps tendon transfers | |
| Group 2 | Subjects with biceps-to-triceps tendon transfers | |
| Group 3 | Subjects with cervical SCI who have not had tendon transfers | |
| Group 4 | Unimpaired control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow Extension Strength
Elbow extension strength was measured as the maximum elbow extension moment that subject's could generate. We used an elbow moment transducer to measure elbow moments under isometric (no change in arm posture) conditions. Subjects performed three trials at maximum effort, holding maximum elbow extension for 5 to 7 seconds. The maximum moment was computed as the maximum average moment sustained over a 0.5 second window.
Measured: At least one year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startAug 2011
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Shirley Ryan AbilityLab, Northwestern University, Case Western Reserve University, Loyola University, MetroHealth System, Ohio
- Responsible party
- Sponsor
- Investigators
- Wendy M Murray, PhD, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204736
- Sponsor's protocol ID
- B7515-R
- Status last verified
- Feb 2016
- First submitted
- 15 Sep 2010
- Last updated
- 8 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Surgical Procedures That Restore Elbow Extension
- ClinicalTrials.gov ID
- NCT01204736
- Acronym / sponsor ID
- B7515-R
- Conditions
- Cervical Spinal Cord Injury
- Keywords
- tendon transfer, elbow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Shirley Ryan AbilityLab, Northwestern University, Case Western Reserve University, Loyola University, MetroHealth System, Ohio
- Study start
- Aug 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Posted 7 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Active elbow extension has significant functional benefits for individuals with tetraplegia. The proposed work will provide information to assess how effectively people are using their elbow extension tendon transfers, and whether one surgery works more effectively than the other. This study will provide recommendations to clinicians about the possibility of improving function after surgery using rehab techniques.
Detailed description
Voluntary control of elbow extension significantly improves functional abilities for individuals with tetraplegia. As a result, surgical reconstruction of elbow extension via tendon transfer is considered a fundamental intervention that benefits the patient, even if other tendon transfers aimed at improving hand function are never performed. Presently, there are two common tendon transfer surgeries used to restore elbow extension following spinal cord injury. These are the posterior deltoid to triceps transfer and the biceps to triceps transfer. Both surgeries significantly improve voluntary elbow extension, although there is variability in the amount of control that is restored among patients. This study will directly compare the performance of the posterior deltoid transfer to the biceps transfer with regard to: voluntary elbow extension strength, the ability to activate the transfer, and neural factors associated with voluntary and involuntary control of individual muscles. These comparisons will be made in functionally relevant postures and will provide fundamental information that will improve clinical understanding of the capacity of each of these two procedures to restore elbow extension.
The fundamental hypothesis of this proposal is that an inability to maximally activate the transferred posterior deltoid and the transferred biceps significantly limits the elbow extension moment that can be produced.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Subjects with posterior deltoid-to-triceps tendon transfers |
| Group 2 | – | –Subjects with biceps-to-triceps tendon transfers |
| Group 3 | – | –Subjects with cervical SCI who have not had tendon transfers |
| Group 4 | – | –Unimpaired control subjects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Three groups of subjects will be recruited to participate in the experiments: individuals that have had the posterior deltoid to triceps tendon transfer, individuals that have the biceps to triceps tendon transfer, and individuals with SCI between C5-C7 who have not had tendon transfers. Nominally, we plan to recruit 15 subjects from each group.
Key inclusion criteria (3 listed)
- Cervical Spinal Cord Injury (C5-C7)
- Posterior Deltoid to Triceps Tendon Transfer at least one year post-surgery
- Biceps to Triceps Tendon Transfer at least one year post-surgery
Key exclusion criteria (7 listed)
- Subjects will be excluded from the studies if there is presence of concurrent severe medical illness, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elbow Extension Strength
Time frame: At least one year post surgery
Elbow extension strength was measured as the maximum elbow extension moment that subject's could generate. We used an elbow moment transducer to measure elbow moments under isometric (no change in arm posture) conditions. Subjects performed three trials at maximum effort, holding maximum elbow extension for 5 to 7 seconds. The maximum moment was computed as the maximum average moment sustained over a 0.5 second window.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy M Murray, PhD principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elbow Extension Strength (time frame: At least one year post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.