Mini-Open Subpectoral Biceps Tenodesis

NCT ID: NCT07014813

Last Updated: 2025-06-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Bicep Tendinitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Sub pectoral fixation

Intervention Type 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.

Interventions

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Sub 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hesham Abd ElGhafour Abd ElRady

Assistant Lecturer at Department of Trauma and orthopedics, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al Kasr Al-Einy

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RC-1910-2024

Identifier Type: -

Identifier Source: org_study_id

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