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OpenTrials
Completed

NCT Number: NCT07014813

Mini-Open Subpectoral Biceps Tenodesis

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.

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Key information

Conditions

Bicep Tendinitis

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Kasr Al-Einy

Cairo, 11451, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

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.

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.

    Time frame: 42 Months

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Mini Open Subpectoral Press Fit Biceps Tenodesis

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

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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