A Prospective Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis

A Prospective Randomized Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03529162

Enrollment

Registered

2018-05-18

Start date

2018-10-19

Completion date

2020-01-27

Last updated

2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biceps Tendon Disorder, Biceps; Tenosynovitis, Bicep Tendinitis

Keywords

Biceps Tendinitis, Subpectoral biceps tenodesis, Biceps tendon disorder

Brief summary

This is a prospective randomized controlled trial comparing two common techniques of long head of biceps tendon tenodesis in shoulder surgery. Numerous techniques of biceps tenodesis currently exist and are commonly performed. We will be comparing the tenodesis procedure using a suture anchor device versus a technique where the tendon is simply sutured to the pectoralis major tendon.

Detailed description

Biceps tenodesis is a commonly performed procedure in shoulder surgery. In many cases, it is performed in conjunction with a rotator cuff repair. Currently, biceps tenodesis is performed in many different ways depending on surgeon preference. First, the location of the tenodesis can vary, as surgeons may prefer a suprapectoral or subpectoral tenodesis location. In addition, the tenodesis fixation technique can also vary, as surgeons have the option to use a screw or suture anchor to perform the tenodesis. There have been numerous studies comparing these various techniques, including suprapectoral versus subpectoral techniques and screw versus suture anchor techniques. None of these studies have been conclusive, and there continues to be controversy as to the best technique. The current study will compare two techniques of subpectoral biceps tenodesis. Specifically, we will compare tenodesis using a suture anchor versus a technique where the tendon is simply sutured to the pectoralis major tendon. The latter technique has been previously described and published.

Interventions

PROCEDURELong head of Biceps Tenodesis

Patients will be randomized into two different groups to compare biceps tenodesis techniques

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Prospective Randomized Controlled Trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 18 - 100 years * Able to provide written informed consent * Has: (a) partial- or full-thickness rotator cuff tear verified by preoperative magnetic resonance imaging (MRI) and arthroscopy; (b) concomitant biceps lesions (LHBT partial tear\>50%, SLAP type II lesion, pulley lesion, or subluxation/dislocation of LHBT) that were diagnosed arthroscopically with concomitant symptoms; and (c) arthroscopic rotator cuff repair.

Exclusion criteria

* Any medical illness that adversely impacts the patient's ability to complete the study procedures * Isolated glenohumeral pathological conditions * Any prior surgery on the same shoulder * Complete rupture of the LHBT assessed by MRI or at time of procedure * Incomplete repair of the rotator cuff

Design outcomes

Primary

Measure	Time frame	Description
Change in Long Head of the Biceps Tendon Score (LHB)	This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.	The LHB score is a composite endpoint (maximum 100 points) that evaluates 'biceps pain and muscle cramps', 'cosmesis', and 'flexion strength at the elbow'. It is an outcome score specific for biceps tendon pathology. The score range is 0-100, with a higher score representing better function. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.

Secondary

Measure	Time frame	Description
Change in Visual Analogue Scale (VAS)	This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.	The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. 0 is no pain and 10 is the worst pain. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Change in Disabilities of the Arm, Shoulder, and Hand Score (DASH)	This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.	The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Change in Single Assessment Numeric Evaluation (SANE)	This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.	The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measure (PROM). Scoring is 1 to 100, with 100 being the highest function/no pain score. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Change in American Shoulder and Elbow Surgeons (ASES) Shoulder Score	This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.	The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology regardless of their specific diagnosis. The ASES score contains a physician-rated and patient-rated section; however, only the pain visual analog scale (VAS) and 10 functional questions are typically used to tabulate the reported ASES score. The total score - 100 maximum points - is weighted 50% for pain and 50% for function. A score of 100 represents a better outcome and a score of 0 represents a worse outcome. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Suture Anchor Technique (SA) If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor. Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques	2
Pectoralis Major Technique (PMT) If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon. Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques	2
Total	4

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	2

Baseline characteristics

Characteristic	Suture Anchor Technique (SA)	Pectoralis Major Technique (PMT)	Total
Age, Continuous	51 years	43 years	47 years
Long Head of the Biceps Tendon Score (LHB)	80 scores on a scale	38 scores on a scale	42 scores on a scale
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	2 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	1 Participants	0 Participants	1 Participants
Sex: Female, Male Female	1 Participants	2 Participants	3 Participants
Sex: Female, Male Male	1 Participants	0 Participants	1 Participants
Single Assessment Numeric Evaluation (SANE)	35 score on a scale	12.5 score on a scale	27.5 score on a scale
The American Shoulder and Elbow Surgeons Shoulder Score (ASES)	23.3 scores on a scale	25.0 scores on a scale	25 scores on a scale
The Disabilities of the Arm, Shoulder and Hand Score (DASH)	49.5 scores on a scale	62 scores on a scale	49.5 scores on a scale
Visual Analog Scale (VAS)	8.5 score on a scale	9 score on a scale	9 score on a scale

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 2	0 / 2
other Total, other adverse events	0 / 2	0 / 2
serious Total, serious adverse events	0 / 2	0 / 2

Outcome results

Primary

Change in Long Head of the Biceps Tendon Score (LHB)

The LHB score is a composite endpoint (maximum 100 points) that evaluates 'biceps pain and muscle cramps', 'cosmesis', and 'flexion strength at the elbow'. It is an outcome score specific for biceps tendon pathology. The score range is 0-100, with a higher score representing better function. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.