Tendon RuptureCoBNCT06602414
Evaluation of Clinical Results of Patients Treated Conservatively for Distal Biceps Tendon Lesions
An observational study of Tendon Rupture, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
A clinical evaluation of the results of conservative treatment after distal biceps tendon rupture with a minimum follow up of 1 year. The results will be evaluated with clinical scores (MEPS, DASH and SF-12) and strenght and fatigue evaluations with dynamometers for both flexion and supination of elbow and forearm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendon Rupture
- What is being tested?
- Conservative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 31 Oct 2024to 1 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who have suffered an acute distal biceps tendon rupture
Who may be able to join
- Age greater than or equal to 18 years old at time of injury
- Complete acute distal biceps tendon rupture diagnosed and evaluated at IRCCS Istituto ortopedico Rizzoli between 2000 and 2024 treated conservatively
Who cannot join
- \< 18 years at time of injury
- Patients who present controindications to the strenght evaluation
- Patients who have developed other non correlated injuries to the affected arm (e.g. fractures or tendon injuries)
- Patients treated surgically for distal biceps tendon rupture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Conservative Treatment Still an Option for Distal Biceps Tendon Lesions? Evaluation of Clinical Results of Patients Treated Conservatively for Distal Biceps Tendon Lesions at 1 Year Minimum Follow-up
A clinical evaluation of the results of conservative treatment after distal biceps tendon rupture with a minimum follow up of 1 year.
The results will be evaluated with clinical scores (MEPS, DASH and SF-12) and strenght and fatigue evaluations with dynamometers for both flexion and supination of elbow and forearm. The results of the affected side will be compared with the controlateral side
- Conditions
- Tendon Rupture
- Being tested
- Conservative treatment
- Keywords
- Distal Biceps tendon rupture, Elbow tendon ruptures, Elbow tendon ruptures conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatmentProcedure or surgery
Conservative treatment instead of surgical repair
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Patients treated conservatively for distal biceps tendon rupture Receives: Procedure: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow Function
The Mayo Elbow Performance score (MEPS) or Mayo Elbow Performance Index (MEPI) is an instrument used to test the limitations, caused by pathology, of the elbow during activities of daily living (ADL) . This specific test uses 4 subscales:
Pain, Range of Motion (arc of motion of the art. humeroulnaris) Stability Daily Function MEPS can be used to measure which treatment work best for different conditions, An example would be when deciding the best post-operative treatment for example: the difference in prognosis between open and closed fractures when operated.
This numerical scale express results on a scale from 0 to 100 and considers results with a score higher than 85 as excellent results.
Measured: At baseline (day 0)
Secondary outcomes (6)
Upper Limb Function
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
The QuickDASH is an abbreviated version of the original DASH outcome measure. In comparison to the original 30 item DASH outcome measure, the QuickDASH only contains 11 items It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level.
The DASH score expresses results on a scale from 0 to 100 with 0 considered as no disabilities and 100 as maximum disability.
Measured: At baseline (day 0)
Short Form Health Survey
The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health. It is a reduced size version of the SF-36, and is widely used since it produces similar results for physical and mental health scores with far less respondent burden for producing scores of overall mental and physical well-being.
The mean score obtained by the US population is 50 points, any differentiation of 10 points represents a difference of 1 standard deviation from the mean values.
Measured: At baseline (day 0)
Flexion strenght
Measured with dynamometer considering the maximum value obtained out of 10 repetition, expressed in Kg.
Measured: At baseline (day 0)
Flexion Fatigue
Measuring the difference of strenght between the first and final pull of a series of 10 repetitions. Expressed in Kg
Measured: At baseline (day 0)
Supination Strenght
Measured with dynamometer considering the maximum value obtained out of 10 repetition, expressed in Kg.
Measured: At baseline (day 0)
Supination Fatigue
Measuring the difference of strenght between the first and final pull of a series of 10 repetitions. Expressed in Kg
Measured: At baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Oct 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602414
- Sponsor's protocol ID
- 340/2024/Oss/IOR
- Acronym
- CoB
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Srinivasan RC, Pederson WC, Morrey BF. Distal Biceps Tendon Repair and Reconstruction. J Hand Surg Am. 2020 Jan;45(1):48-56. doi: 10.1016/j.jhsa.2019.09.014.
PubMed 31901332Athwal GS, Steinmann SP, Rispoli DM. The distal biceps tendon: footprint and relevant clinical anatomy. J Hand Surg Am. 2007 Oct;32(8):1225-9. doi: 10.1016/j.jhsa.2007.05.027.
PubMed 17923307
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Conservative Treatment Still an Option for Distal Biceps Tendon Lesions? Evaluation of Clinical Results of Patients Treated Conservatively for Distal Biceps Tendon Lesions at 1 Year Minimum Follow-up
- ClinicalTrials.gov ID
- NCT06602414
- Acronym / sponsor ID
- CoB / 340/2024/Oss/IOR
- Conditions
- Tendon Rupture
- Keywords
- Distal Biceps tendon rupture, Elbow tendon ruptures, Elbow tendon ruptures conservative treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- 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.
A clinical evaluation of the results of conservative treatment after distal biceps tendon rupture with a minimum follow up of 1 year.
The results will be evaluated with clinical scores (MEPS, DASH and SF-12) and strenght and fatigue evaluations with dynamometers for both flexion and supination of elbow and forearm. The results of the affected side will be compared with the controlateral side
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | – | Procedure: Conservative treatmentPatients treated conservatively for distal biceps tendon rupture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have suffered an acute distal biceps tendon rupture
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years old at time of injury
- Complete acute distal biceps tendon rupture diagnosed and evaluated at IRCCS Istituto ortopedico Rizzoli between 2000 and 2024 treated conservatively
Key exclusion criteria (4 listed)
- \< 18 years at time of injury
- Patients who present controindications to the strenght evaluation
- Patients who have developed other non correlated injuries to the affected arm (e.g. fractures or tendon injuries)
- Patients treated surgically for distal biceps tendon rupture
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 |
|---|---|---|
| Conservative treatmentConservative treatment instead of surgical repair | Procedure or surgery | Conservative treatment |
Primary outcome
Elbow Function
Time frame: At baseline (day 0)
The Mayo Elbow Performance score (MEPS) or Mayo Elbow Performance Index (MEPI) is an instrument used to test the limitations, caused by pathology, of the elbow during activities of daily living (ADL) . This specific test uses 4 subscales: Pain, Range of Motion (arc of motion of the art. humeroulnaris) Stability Daily Function MEPS can be used to measure which treatment work best for different conditions, An example would be when deciding the best post-operative treatment for example: the difference in prognosis between open and closed fractures when operated. This numerical scale express results on a scale from 0 to 100 and considers results with a score higher than 85 as excellent results.
6 secondary outcomes
Upper Limb Function
Time frame: At baseline (day 0)
Short Form Health Survey
Time frame: At baseline (day 0)
Flexion strenght
Time frame: At baseline (day 0)
Flexion Fatigue
Time frame: At baseline (day 0)
Supination Strenght
Time frame: At baseline (day 0)
Supination Fatigue
Time frame: At baseline (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 31901332Srinivasan RC, Pederson WC, Morrey BF. Distal Biceps Tendon Repair and Reconstruction. J Hand Surg Am. 2020 Jan;45(1):48-56. doi: 10.1016/j.jhsa.2019.09.014.
- Background: PubMed 17923307Athwal GS, Steinmann SP, Rispoli DM. The distal biceps tendon: footprint and relevant clinical anatomy. J Hand Surg Am. 2007 Oct;32(8):1225-9. doi: 10.1016/j.jhsa.2007.05.027.
- Individual participant dataSharing planned: No
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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.
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 Tendon Rupture, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 2 inclusion and 4 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 2 Jul 2026. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Function (time frame: At baseline (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06602414, which also lists 2 linked publications.
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 2 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.