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

Recruiting

• Conditions: Tendon Rupture
• Interventions: Procedure: Conservative treatment

• Registration Number: NCT06602414
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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. The results of the affected side will be compared with the controlateral side

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Study Start: 2024-10-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Conservative treatment	Patients treated conservatively for distal biceps tendon rupture

Primary Outcome Measures

Name	Time	Method
Elbow Function	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 Outcome Measures

Name	Time	Method
Upper Limb Function	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.
Short Form Health Survey	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.
Flexion strenght	At baseline (day 0)	Measured with dynamometer considering the maximum value obtained out of 10 repetition, expressed in Kg.
Flexion Fatigue	At baseline (day 0)	Measuring the difference of strenght between the first and final pull of a series of 10 repetitions. Expressed in Kg
Supination Strenght	At baseline (day 0)	Measured with dynamometer considering the maximum value obtained out of 10 repetition, expressed in Kg.
Supination Fatigue	At baseline (day 0)	Measuring the difference of strenght between the first and final pull of a series of 10 repetitions. Expressed in Kg

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy