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Completed

NCT Number: NCT06602414

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

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

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Key information

Conditions

Tendon Rupture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conservative treatment

Procedure

Conservative treatment instead of surgical repair

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Flexion strenght

    Time frame: At baseline (day 0)

    Measured with dynamometer considering the maximum value obtained out of 10 repetition, expressed in Kg.

  4. 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

  5. Supination Strenght

    Time frame: At baseline (day 0)

    Measured with dynamometer considering the maximum value obtained out of 10 repetition, expressed in Kg.

  6. 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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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

Acronym: CoB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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