Evaluation of Clinical Results of Patients Treated Conservatively for Distal Biceps Tendon Lesions (CoB)

March 23, 2026 updated by: Istituto Ortopedico Rizzoli

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients who have suffered an acute distal biceps tendon rupture

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • < 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conservative treatment
Patients treated conservatively for distal biceps tendon rupture
Procedure: Conservative treatment
Conservative treatment instead of surgical repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flexion strenght
Time Frame: At baseline (day 0)
Measured with dynamometer considering the maximum value obtained out of 10 repetition, expressed in Kg.
At baseline (day 0)
Flexion Fatigue
Time Frame: At baseline (day 0)
Measuring the difference of strenght between the first and final pull of a series of 10 repetitions. Expressed in Kg
At baseline (day 0)
Supination Strenght
Time Frame: At baseline (day 0)
Measured with dynamometer considering the maximum value obtained out of 10 repetition, expressed in Kg.
At baseline (day 0)
Supination Fatigue
Time Frame: At baseline (day 0)
Measuring the difference of strenght between the first and final pull of a series of 10 repetitions. Expressed in Kg
At baseline (day 0)
Upper Limb Function
Time Frame: At baseline (day 0)

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.
At baseline (day 0)
Short Form Health Survey
Time Frame: At baseline (day 0)

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.
At baseline (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2024

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

July 1, 2025

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 340/2024/Oss/IOR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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