Labral repair vs Biceps Tenodesis vs Sham Surgery for SLAP Lesions of the shoulder

CP Schrøder MD, Ø Skare MT, PhD, P Mowinkel, MSc,

O Reikerås MD, PhD, JI Brox, MD, PhD

SLAP (superior labrumanterior to posterior)-lesions

SLAP II lesions´ Outcomes after Type II SLAP repair:(Gorantla et al, Arthroscopy 2010, Huri, McFarland et al, 2014)

´ No randomized trials, few prospective studies

´ Good to excellent results; 40 to 94 %

´ Return to previous level of sports; 20 to 94%

´ Biceps tenodesis may present a viable treatment for SLAP repair

because of a high failure rate of SLAP repair

´ Labral repair most common surgical approach

Increasing incidence in repairs past 10 years, especially in the middle aged and elderly.

(Vogel et al, J Shoulder Elbow Surg, 2014, Weber et al, Am J Sports Med, 2012)

The incidence of repair is associated with a significant rate of complications and poor outcomes. (Weber et al. Sports Med Arthrosc,2010, Katz et al. Arthroscopy 2009)

N° & percentage of SLAP repair has decreased, the age undergoing repair has decreased, while biceps tenodesis is increasing. (Erickson BJ, et al.Arthroscopy, in press, available online febr 2016.)

SLAP repairs are still performed world wide routinely, but evidence of its efficacy is lacking….

´ We have conducted a prospective, double-blind, sham controlled trial

´ The aim of the study was to compare the efficacy of labral repair, biceps tenodesis and sham surgery for alleviating and improving function in patients with type II SLAP tears

Design, patients and outcome

´ From January 2008 to January 2014´ 118 patients, age 40.1 years (18-60)´ History & clinical signs (O`Brien, Apprehension test)

suspecting a Type II SLAP lesion, verified by arthro-MRI´ Randomization at arthroscopy to labral repair, biceps

tenodesis or sham surgery if an isolated Type II lesion was diagnosed

´ Validated outcome measures for SLAP lesions (Rowe, WOSI, OISS) (Skare et al. J Shoulder Elbow Surg 2011, BMC Research Notes,2013)

´ All three groups had similar postoperative physiotherapy´ Endpoint 6 months and 2 years´ Primary outcomes: Rowe score and WOSI score´ Secondary outcomes: Oxford Instability Shoulder Score

(OISS), EQ-5D, EQ-VAS and patient satisfaction´ The results were analyzed and interpreted blindly at 6

months

Ethics, blinding and sample size

´ Ethical approval ´ The patients were informed that if they were not

satisfied with their shoulder function at 6 months, the blinding could be unfolded

´ Blinding checked by asking the patients whether they thought were in the surgically intervention or the sham-group

´ From experience we estimated the clinically important detectable difference to 10 points on the 100 points Rowe score. To detect this difference between treatment groups (SD = 15, α = 0.05, ß = 0.80, One-Way ANOVA) the study required 36 patients in each group. Assuming 10% drop-out, we planned to include 40 patients in each group

Statistics

- Blinded experienced statistician - Primary Intention to treat analysis- Secondary per-protocol analysis- Adjusted between- group differences (age, gender,

baseline score, trauma, manual work, time)- Imputation of missing values

SurgeryA video from the subacromial space and the glenohumeral joint was created for each patient

Labral repair;

Debridement of the superior glenoid rim, percutaneous placed drilling and

suture anchor placement, anchors placed posterior to the biceps insertion,

simple circular sutures.

Biceps tenodesis;

Percutaneously placed spinal needle at 90° angle through

the biceps in the bicipital sulcus, Biceps tenotomy at the

insertion, skin incision max 2 cm, follow the spinal needle with

A knife, open the pulley and luxate the biceps tendon,

debride the groove and place a double loaded anchor as distal as

possible in the bicipital groove.

Sham;

Diagnostic arthroscopy, sham incision mimicking a SLAP repair.

Postoperative physiotherapy

´ Standardized, individually adjusted ´ Pendulum exercises 1. postoperative day´ Sling for 3 weeks´ Local physio/manual therapists ´ Massage & stretching, core stability exercises, general

physical training´ Scapula-humeral rhythm, coordination and mobility

using sling-exercise therapy´ Functional stability, rotator cuff and scapular strength,

progressively emphasized after 6 weeks.´ Sports and job-specific rehab starting 3 months post-

op.´ Rehab continued for 3 to 6 months, 12-16 sessions, 20

self-administered sessions.

Assessed for eligibility (n=445 )

Excluded (n= 262 )¨ Not meeting inclusion criteria, (AC-

pathology, SLAP with cysts etc) (n=227 )¨ Declined to participate (n= 14 )¨ Other reasons (n= 21 )

Lost to follow-up (did not show up for 6 months control) (n= 1 )

Allocated to sham-surgery (n= 39 )

Lost to follow-up (n= 0 )

Allocated to labral repair (n= 40 )

Underwent arthroscopy(n= 183 )

Allocated to biceps tenodesis(n= 39 )

Lost to follow-up (did not show up for 6 months control) (n= 1 )

Excluded peroperatively (n=65 )•No SLAP tear (n= 19 )•Large posterior labral tear (n= 11 )•Cufftear (n= 8 )•360° labral tear (n= 7)•Bankart lesion (n= 7)•Partial biceps tear (n= 7)•Bucket handle tear (n= 3)•Capsulitis (n= 3)

Underwent randomisation (n= 118 )

Flow chart

Lost to follow-up (did not show up for 1 year control (n = 3 )

Lost to follow-up (did not show up for 1 year control (n = 0 )

Lost to follow-up (did not show up for 1 year control (n = 1 )

Analysed (n = 37 ) lost to follow-up 2 year (n = 2 )

Analysed ( n = 38 ) lost to follow-up 2 year (n = 1 )

Analysed (n = 39) lost to follow-up 2 year (n = 1)

4 lost to follow-up at 2 years

Rowe Score 2 yearsIntention to treat

Sham: 86.5

Biceps tenodesis:

86.8

Labral repair:

86.3

Results

WOSI 2 years

Sham: 436

Biceps: 455

Labrum: 334

Results

Oxford Instability Shoulder Score(OISS) Results

Mean between-group differences (95% Confidence Interval)

Rowe 6 months: biceps vs labrum 0.2 (-7.5 to 7.1)biceps vs sham 0.2 (-7.5 to 7.1)labrum vs sham -0.2 (-7.5 to 7.1)

Rowe 24 months: biceps vs labrum 1.0 (-5.4 to 7.5)biceps vs sham 1.6 (-5.0 to 8.1)labrum vs sham 0.6 (-5.9 to 7.0)

WOSI 6 months: biceps vs labrum -137 (-334 to 61)biceps vs sham -128 (-328 to 71)labrum vs sham 8 (-189 to 205)

WOSI 24 months: biceps vs labrum -96 (-209 to 77)biceps vs sham 22 (-152 to197)labrum vs sham 118 (-54 to 292) ns

Results

Prolonged postoperative stiffness

Labral repair: 5Biceps tenodesis: 4Sham surgery: 1

Reoperations n = 24 :

Results

Labral repair

Bicepstenodesis

AC-jointresection

Capsularrelease

Sham 12 2 - -

Bicepstenodesis

3 - 1 2

Labral repair - 3 1 -

Patient satisfaction

excellent good fair poor total EQ-5 VAS

Sham 19 12 84% 6 0 37 77.3

Bicepstenodesis

25 9 89% 1 3 38 80.0

Labralrepair

23 6 83% 5 1 35 81.9

Results

Not physically active sign lower EQ-VAS, p = 0.02

Per Protocol Analysis

Follow-up Labral repair

Bicepstenodesis

Sham Sham cross over

6 months 549 728# 467* 823

12 months 414* 521* 329* 819

24 months 304* 402 303* 681# Sign.worse than sham* Sign better than cross-over

Results

Rowe

WOSI*Sign. better than cross-over

Cross-overs

8/14 with Rowe over 80 and rated the shoulder asexcellent/good

Strengths & Limitations´ Sample size:- The CI intervals of the observed between-group differences indicate

that the study was adequately sized to detect a clinical relevant difference between the three groups

´ Relevant outcome measures: - Both subjective and objective scores used, validated by Skare et al

for the use of patients with SLAP lesions´ Blinding:- 73 % of the patients in the sham group, 87% in the labral repair group

and 97% in the biceps tenodesis believed they had been operated. - Blinding of assessors, statistician and authors.´ Strict inclusion criteria:- High internal validity, but low external validity´ Local physio/manual – therapist; high external validity´ No cross-over at 6 months

Conclusions

´ There is a significant improvement for all groups, both for objective and subjective scores.

´ No significant difference between the three treatment groups.

´ The groups are not large enough to perform sub-group analysis and further studies are needed to establish whether younger and more active patients will receive greater benefit from operative than non-operative treatment.

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