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

NCT06602414 | Completed

• 1 other identifier: 340/2024/Oss/IOR
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Tendon Rupture

Keywords

Distal Biceps tendon rupture; Elbow tendon ruptures; Elbow tendon ruptures conservative treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (day 0)

Secondary Outcomes (6)

• Upper Limb Function

  At baseline (day 0)

• Short Form Health Survey

  At baseline (day 0)

• Flexion strenght

  At baseline (day 0)

• Flexion Fatigue

  At baseline (day 0)

• Supination Strenght

  At baseline (day 0)

Study Arms (1)

Conservative treatment

Patients treated conservatively for distal biceps tendon rupture

Procedure: Conservative treatment

Interventions

Conservative treatment PROCEDURE

Conservative treatment instead of surgical repair

Conservative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who have suffered an acute distal biceps tendon rupture

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

Related Publications (2)

• 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.

  PMID: 31901332 BACKGROUND

• 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.

  PMID: 17923307 BACKGROUND

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: October 31, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IT (1)