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CompletedNCT07014813Updated Jun 11, 2025

Mini-Open Subpectoral Biceps Tenodesis

An interventional study of Sub pectoral fixation in Bicep Tendinitis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 5 months after the study started (first participant enrolled Jan 2021, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bicep Tendinitis

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03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with avascular necrosis or arthritis.
  • Extensive bone loss.
  • Poor bone density.
  • Active infection.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    Candidate Group

    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

  • ProcedureSub pectoral fixation

    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.

06

What researchers measure

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.

    Time frame: 42 Months

07

Study locations

1 site
  • Al Kasr Al-Einy
    Cairo, 11451, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07014813
Lead sponsor
Cairo University
Responsible party
Hesham Abd ElGhafour Abd ElRady (Assistant Lecturer at Department of Trauma and orthopedics, Faculty of Medicine, Cairo University) — Principal investigator
First posted
Jun 11, 2025
Start date
Jan 1, 2021
Primary completion
Apr 15, 2024
Completion
Aug 1, 2024
Last update
Jun 11, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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