Randomized controlled trial of intra-articular versus sub-pectoral long head of bicep tenodesis in the treatment patients with biceps pathology accompanied with rotator cuff tears
(1) Objectives: to compare intra-articular versus sub-pectoral long head of bicep tenodesis in the treatment of biceps pathology accompanied with rotator cuff tears. (2) Design: Randomized controlled trial. (3) Setting and conduct: Sample size of 60 patients will randomly assign into intervention (Intra-articular) or control (sub-pectoral) group and will be treated in academic orthopedic hospital. (4) Participants: Inclusion criteria: All rotator cuff tore patients with at least one positive biceps tendon test; Inflammation, partial tear, dislocation, or SLAP lesion; Age between 14 and 65 years; No sign of extensive fatty infiltration in MRI. Exclusion criteria: History of shoulder surgery; Pain or need for surgery of both shoulders; Impossible arthroscopic repair of rotator cuff during surgery and change of arthroscopic surgery into open surgery. (5) Interventions: Intra-articular tenodesis using anchor sutures will be performed in the first group. In the second group, after intra-articular tenotomy, mini open sub pectoral approach will be employed to execute tenodesis using bio absorbable interference screw. (6) Main outcome measures: Primary outcome is VAS score of pain which will be assessed pre-treatment, 6 month and one year after surgery. Secondary outcomes are VAS score of patients satisfaction, Constant score and simple shoulder test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309247274N9
Registration date:2013-10-23, 1392/08/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-23, 1392/08/01
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2013-06-17, 1392/03/27
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized controlled trial of intra-articular versus sub-pectoral long head of bicep tenodesis in the treatment patients with biceps pathology accompanied with rotator cuff tears
Public title
Comparison between two tenodesis methods in the treatment of biceps tendon and shoulder pathology.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All rotator cuff tore patients with at least one positive biceps tendon test (speed test, Yergoson test, active compression test or biceps instability); Inflammation, partial tear, dislocation, or SLAP lesion; Age between 14 and 65 years; No sign of extensive fatty infiltration in MRI. Exclusion criteria: History of shoulder surgery; Pain or need for surgery in both shoulders; Impossible arthroscopic repair of rotator cuff during surgery and change of arthroscopic surgery into open surgery.
Age
From 14 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Guilan University of Medical Sciences
Street address
Research vice-chancellor of Guilan university of medical sciences building, Shahid Beheshti blv.
City
Rasht
Postal code
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
1920101207
Health conditions studied
1
Description of health condition studied
Long head of biceps tendinitis
ICD-10 code
M75.2
ICD-10 code description
Bicipital tendinitis
Primary outcomes
1
Description
Pain intensity
Timepoint
before, 6 months and one year after surgery
Method of measurement
Visual Analogue Scale score (VAS)
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
before, 6 months and one year after surgery
Method of measurement
Visual Analogue Scale score (VAS)
2
Description
Functional status of shoulder
Timepoint
Before, 6 months and one year after surgery
Method of measurement
Constant score
3
Description
Functional status of shoulder
Timepoint
Before, 6 months and one year after surgery
Method of measurement
Simple Shoulder Test
Intervention groups
1
Description
First group-intervention (Intra-articular tenodesis): During arthroscopic treatment of rotator cuff tear, Intra-articular tenodesis using anchor sutures will be performed.
Category
Treatment - Surgery
2
Description
Second group-Control (Sub-pectoral tenodesis): After intra-articular tenotomy, mini open sub pectoral approach will be employed to execute tenodesis using bio absorbable interference screw.