Mini-Open Subpectoral Biceps Tenodesis

NCT07014813 | Completed

• 1 other identifier: RC-1910-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical management of long head of biceps (LHB) lesions is frequent, often alongside other shoulder issues. When conservative treatment fails, tenotomy (for low-demand patients) or tenodesis (preferred for active individuals) is performed. Subpectoral tenodesis offers advantages, and this study assesses a novel press-fit bony plug technique for this approach, evaluating its safety and efficacy.

Conditions

Bicep Tendinitis

Outcome Measures

Primary Outcomes (1)

• The proportion of patients reported having at least a 50% Increase in their Amircan Shoulder and Elbow Society (ASES) Scoring, and decrease in their pain (measured according to VAS score) with no loss in the range of motion.

  The Success rate of sub-pectoral fixation of the biceps tendon was assessed as that there was proportion of patients who achieved a clinically significant improvement in shoulder and elbow function (at least a 50% increase in ASES score), a notable reduction in pain (decrease in VAS score), while maintaining their ange of motion.

  42 Months

Study Arms (1)

Candidate Group

OTHER

The Candidate Group Patients were 30 patients: * Seventeen females and Thirteen males with a mean age of 44.4 years (range: 30-60 years). * Eight patients were smokers, and ten suffered from controlled diabetes. * Three patients were suffering from isolated biceps tendinopathy without associated pathology, Nine were suffering from frozen shoulder, Fifteen patients with different degrees of rotator cuff tears, and the last three patients had biceps slap lesions which were irreparable with anchors. * There were 21 dominant and 9 non-dominant shoulders.

Procedure: Sub pectoral fixation

Interventions

Sub pectoral fixation PROCEDURE

Subpectoral biceps tenodesis via mini-open incision. Biceps tendon prepared with Krackow sutures, press-fit into bony tunnel using harvested bone plug. Stability checked post-fixation.

Candidate Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Biceps tendon pathologies after failure of conservative measures: biceps tenosynovitis, recurrent subluxation, or SLAP lesions.
• Young and middle-aged individuals (20-60 years old).

You may not qualify if:

• Patients with avascular necrosis or arthritis.
• Extensive bone loss.
• Poor bone density.
• Active infection.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Al Kasr Al-Einy

Cairo, 11451, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at Department of Trauma and orthopedics, Faculty of Medicine

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: January 1, 2021
• Primary Completion: April 15, 2024
• Study Completion: August 1, 2024
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

EG (1)