Biceps Tendon RuptureNCT01343875
Evaluation the Operative Procedure Among Patients That Suffer From Tear of the Distal Tendon of the Biceps
An observational study of Biceps Tendon Rupture, run by Hadassah Medical Organization.
Trial summary
Background: rupture of the distal tendon in biceps muscle is a rare injury. The state of the art treatment is surgical procedure. Objective: Evaluation of the Surgical procedure among patients that suffered from Methods: The investigators will review files from 2003-2010 of patients that gone through the operation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Biceps Tendon Rupture
- What is being tested?
- tear of the distal tendon in the biceps muscle
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: men and women that went to surgery due to tear of the distal tendon in the biceps muscle.
Who may be able to join
- 1.see population description
Who cannot join
- 1. Unwillingness to come to the clinic visit.
About this study
Background: rupture of the distal tendon in biceps muscle is a rare injury. The state of the art treatment is surgical procedure.
Objective: Evaluation of the Surgical procedure among patients that suffered from Methods: The investigators will review files from 2003-2010 of patients that gone through the operation. The investigators will record pre-operation and post-operation process including complications and rehabilitation. The investigators will invite them to the clinic for exams, clinical questionnaires.
- Conditions
- Biceps Tendon Rupture
- Being tested
- tear of the distal tendon in the biceps muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tear of the distal tendon in the biceps muscleProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| surgery, biceps tear | Not described Receives: Procedure: tear of the distal tendon in the biceps muscle |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biceps Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Case crossover
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343875
- Sponsor's protocol ID
- beyth03-HMO-CTIL
- Status last verified
- Dec 2011
- First submitted
- 27 Apr 2011
- Last updated
- 28 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Operative Procedure Among Patients That Suffer From Tear of the Distal Tendon of the Biceps
- ClinicalTrials.gov ID
- NCT01343875
- Acronym / sponsor ID
- beyth03-HMO-CTIL
- Conditions
- Biceps Tendon Rupture
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: rupture of the distal tendon in biceps muscle is a rare injury. The state of the art treatment is surgical procedure.
Objective: Evaluation of the Surgical procedure among patients that suffered from Methods: The investigators will review files from 2003-2010 of patients that gone through the operation. The investigators will record pre-operation and post-operation process including complications and rehabilitation. The investigators will invite them to the clinic for exams, clinical questionnaires.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery, biceps tear | – | Procedure: tear of the distal tendon in the biceps muscle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men and women that went to surgery due to tear of the distal tendon in the biceps muscle.
Key inclusion criteria (1 listed)
- 1.see population description
Key exclusion criteria (1 listed)
- 1. Unwillingness to come to the clinic visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tear of the distal tendon in the biceps muscle | Procedure or surgery | surgery, biceps tear |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Biceps Tendon Rupture, run by Hadassah Medical Organization.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 28 Dec 2011.