Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT01747902
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2012-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biceps Tenodesis Versus Tenotomy
Sponsor:
Panam Clinic
Organization:
Study Overview
Official Title:
Biceps Tenodesis Versus Tenotomy in the Treatment of Lesions of the Long Head of Biceps Brachii: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BicepsTvsT
Brief Summary:
The long head of biceps brachii tendon has been known to be a pain generator and a common cause of shoulder pain and dysfunction in patients with rotator cuff pathology. Both biceps tenotomy and tenodesis have been shown to produce comparable results, but there is no consensus to date due to a lack of level I evidence. The aim of this prospective, randomized, clinical trial is to compare subjective patient-reported outcomes and objective clinical results between biceps tenotomy and biceps tenodesis for treating lesions of the long head of the biceps brachii.
Detailed Description:
Methodology
Patients will be screened in clinic and, if deemed appropriate for the study, will be approached by the research coordinator who will review the study and provide the opportunity for consenting to participate. The surgical procedure will be performed using standard arthroscopic technique and patients will be randomized intra-operatively via computer randomization when a biceps tendon lesion is confirmed. The type of anchor for the tenodesis, whether bioabsorbable or metal, and the manufacture of the anchor used is at the discretion of the surgeon. Duration of the surgery will be between 60-120 minutes.
Surgical Technique
The technique can be done using a biceps groove or a subpectoral level of fixation depending on surgeon preference. Shoulder arthroscopy is conducted in the lateral decubitus or beach chair position. Diagnostic arthroscopy is performed using a standard posterior portal and the biceps tendon is assessed with an arthroscopic probe using a standard anterior interval portal. Once study eligibility was confirmed via identification of tearing or degeneration of the long head of biceps, the patient was randomized to undergo either tenodesis or tenotomy.
For patients who undergo biceps tenotomy the long head of biceps tendon is detached from its proximal anchor to the superior labrum using an arthroscopic biter, an electrothermal device, or a scalpel based on individual surgeon preference.
For those patients undergoing biceps tenodesis, the tendon is tagged with a monofilament suture prior to detaching it from its superior labral attachment. The long head of biceps is then mobilized arthroscopically, and retrieved through an incision either in the groove (which is opened arthroscopically in the subacromial space) or at the inferior border of the pectoralis major tendon. A No. 2 non-absorbable suture is whip-stitched at the appropriate length. The remainder of the biceps tendon is excised and the anterior cortex of the proximal humerus is prepared using a cannulated reamer inserted into the bicipital groove. One suture limb is then passed through an appropriate size interference screw and the tendon is placed within the reamed tunnel. The screw is then advanced until it is flush with bone..
Once the long head of biceps tendon pathology had been addressed, the scope is switched to a standard lateral portal to assess subacromial pathology and the rotator cuff. Subacromial decompression is performed using a cutting block technique if required, and the rotator cuff is repaired if necessary using standard anterolateral and posterolateral accessory portals based on tear configuration.
Post-operative Care and Physiotherapy
Postoperative care and immobilization are identical for the two groups and consist of the use of an immobilizer for 4-6 weeks. Patients are allowed to remove the immobilizer for activities of daily living in which the arm is not abducted and does not externally rotate beyond neutral. Active range of motion is started at 4-6 weeks and resistance exercises are begun when maximal range of motion has been achieved. No at-risk work activities or sports are allowed for six months.
Data Analysis
The primary analysis involves a comparison of the mean ASES scores between the two surgical treatment groups on an intention to treat basis. This analysis is a two sample independent t-test to assess whether there is a statistically significant difference between groups for the mean ASES scores at baseline and each follow-up appointment up to two years. Repeated measures ANOVAs will be used to determine the effect of surgery from baseline to two years post-surgery (i.e. pre-operatively, 3, 6, and 12, and 24 month follow-ups) on ASES scores for each group. The 5% significance level is employed. The underlying assumption for the ASES score data is that there is a normal distribution. If the sample distribution is determined to depart from normal, then a Wilcoxon rank sum test with Bonferroni correction will be performed. The secondary analysis involves a comparison of the secondary outcome measures between the two surgical treatment groups. The elbow strength findings will be analyzed for differences between the two groups at each time point up to 2 years. Repeated measures ANOVAs will be used to determine the effect of surgery from baseline to two years post-surgery (i.e. pre-operatively, 3, 6, and 12, and 24 month follow-ups) on ASES and elbow strength for each group. Nominal demographic data will be compared using the chi-squared test, while ordinal data will be compared using a t-test.
Significance of the Proposed Research
Arthroscopic treatment of lesions of the long head of the biceps tendon, whether tenodesis or tenotomy, has shown consistently favourable results. This trial is necessary both to provide optimal care of our patients, and to do so in a fiscally responsible fashion as the biceps tenodesis procedure has potential cost implications related to additional surgical time and anchor requirements. The results of the trial will provide valuable information regarding the management of lesions of the long head of the biceps tendon. The data obtained from quality of life measurements and physical exam will enable the authors to make recommendations that will lead to maximizing shoulder function and quality of life in patients.
Patients will be screened in clinic and, if deemed appropriate for the study, will be approached by the research coordinator who will review the study and provide the opportunity for consenting to participate. The surgical procedure will be performed using standard arthroscopic technique and patients will be randomized intra-operatively via computer randomization when a biceps tendon lesion is confirmed. The type of anchor for the tenodesis, whether bioabsorbable or metal, and the manufacture of the anchor used is at the discretion of the surgeon. Duration of the surgery will be between 60-120 minutes.
Surgical Technique
The technique can be done using a biceps groove or a subpectoral level of fixation depending on surgeon preference. Shoulder arthroscopy is conducted in the lateral decubitus or beach chair position. Diagnostic arthroscopy is performed using a standard posterior portal and the biceps tendon is assessed with an arthroscopic probe using a standard anterior interval portal. Once study eligibility was confirmed via identification of tearing or degeneration of the long head of biceps, the patient was randomized to undergo either tenodesis or tenotomy.
For patients who undergo biceps tenotomy the long head of biceps tendon is detached from its proximal anchor to the superior labrum using an arthroscopic biter, an electrothermal device, or a scalpel based on individual surgeon preference.
For those patients undergoing biceps tenodesis, the tendon is tagged with a monofilament suture prior to detaching it from its superior labral attachment. The long head of biceps is then mobilized arthroscopically, and retrieved through an incision either in the groove (which is opened arthroscopically in the subacromial space) or at the inferior border of the pectoralis major tendon. A No. 2 non-absorbable suture is whip-stitched at the appropriate length. The remainder of the biceps tendon is excised and the anterior cortex of the proximal humerus is prepared using a cannulated reamer inserted into the bicipital groove. One suture limb is then passed through an appropriate size interference screw and the tendon is placed within the reamed tunnel. The screw is then advanced until it is flush with bone..
Once the long head of biceps tendon pathology had been addressed, the scope is switched to a standard lateral portal to assess subacromial pathology and the rotator cuff. Subacromial decompression is performed using a cutting block technique if required, and the rotator cuff is repaired if necessary using standard anterolateral and posterolateral accessory portals based on tear configuration.
Post-operative Care and Physiotherapy
Postoperative care and immobilization are identical for the two groups and consist of the use of an immobilizer for 4-6 weeks. Patients are allowed to remove the immobilizer for activities of daily living in which the arm is not abducted and does not externally rotate beyond neutral. Active range of motion is started at 4-6 weeks and resistance exercises are begun when maximal range of motion has been achieved. No at-risk work activities or sports are allowed for six months.
Data Analysis
The primary analysis involves a comparison of the mean ASES scores between the two surgical treatment groups on an intention to treat basis. This analysis is a two sample independent t-test to assess whether there is a statistically significant difference between groups for the mean ASES scores at baseline and each follow-up appointment up to two years. Repeated measures ANOVAs will be used to determine the effect of surgery from baseline to two years post-surgery (i.e. pre-operatively, 3, 6, and 12, and 24 month follow-ups) on ASES scores for each group. The 5% significance level is employed. The underlying assumption for the ASES score data is that there is a normal distribution. If the sample distribution is determined to depart from normal, then a Wilcoxon rank sum test with Bonferroni correction will be performed. The secondary analysis involves a comparison of the secondary outcome measures between the two surgical treatment groups. The elbow strength findings will be analyzed for differences between the two groups at each time point up to 2 years. Repeated measures ANOVAs will be used to determine the effect of surgery from baseline to two years post-surgery (i.e. pre-operatively, 3, 6, and 12, and 24 month follow-ups) on ASES and elbow strength for each group. Nominal demographic data will be compared using the chi-squared test, while ordinal data will be compared using a t-test.
Significance of the Proposed Research
Arthroscopic treatment of lesions of the long head of the biceps tendon, whether tenodesis or tenotomy, has shown consistently favourable results. This trial is necessary both to provide optimal care of our patients, and to do so in a fiscally responsible fashion as the biceps tenodesis procedure has potential cost implications related to additional surgical time and anchor requirements. The results of the trial will provide valuable information regarding the management of lesions of the long head of the biceps tendon. The data obtained from quality of life measurements and physical exam will enable the authors to make recommendations that will lead to maximizing shoulder function and quality of life in patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: