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

NCT ID: NCT06602414

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-07-01

Brief Summary

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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

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Conditions

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Tendon Rupture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conservative treatment

Patients treated conservatively for distal biceps tendon rupture

Conservative treatment

Intervention Type PROCEDURE

Conservative treatment instead of surgical repair

Interventions

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Conservative treatment

Conservative treatment instead of surgical repair

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Ortopedico Rizzoli

Bologna, BO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Federico Coliva, MD

Role: CONTACT

+393347781701

References

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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.

Reference Type BACKGROUND
PMID: 31901332 (View on PubMed)

Athwal 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.

Reference Type BACKGROUND
PMID: 17923307 (View on PubMed)

Other Identifiers

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340/2024/Oss/IOR

Identifier Type: -

Identifier Source: org_study_id

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