Functional Outcome Following Shoulder Surgery: A Prospective Database
Conditions: Rotator Cuff Tear
Sponsor: Ottawa Hospital Research Institute

 
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Title: A Multicenter Randomized Controlled Trial Comparing Single-Row With 
Double-Row Fixation in Arthroscopic Rotator Cuff Repair: Long-Term Follow-up 
 
Clinicaltrials.gov NCT00253864 
 
Document Date: 01-Mar-2023 
 
 
 
A clinicaltrials.gov was created for the purpose of publication requirement. 
We have included the protocol below for reference. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Single Versus Double Row Fixation for Arthroscopic Cuff Repair: A 8 Year Long 
Term Follow-up of a Randomized, Controlled Trial  
 
1. Statement of Objectives  
 
In a previous study, ninety patients undergoing arthroscopic rotator cuff repair were 
randomized to receive either a single-row or a double-row repair33. The primary objective 
was to compare the Western Ontario Rotator Cuff Index (WORC) score at twenty- four 
months (from June 2007 to June 2009). Secondary objectives included comparison of the 
Constant and American Shoulder and Elbow Surgeons (ASES) scores and strength between 
groups. Anatomical outcomes were assessed with magnetic resonance imaging (MRI) or 
ultrasonography to determine the postoperative healing rates. 
 
The results of the study published in the Journal of Bone and Joint Surgery – JBJS (Volume 
94-A. Number 14. July 18, 2012) are in agreement with other randomized clinical trials 
comparing single-row and double-row fixation. Our hypothesis that double-row fixation 
yields superior quality of life outcomes compared with single row lateral fixation was not 
supported.  
 
No significant differences between the single-row and double-row groups were found in the 
WORC, ASES, or Constant scores or strength at any time point. However, a smaller initial 
tear size and double-row repair were associated with a greater healing rate.  
 
The original RCT involved a two-year follow-up period. It is our hypothesis that a longer 
follow-up period would have been of value. At a mean of 8 years postoperatively, we will 
follow-up the patients involved in the original RCT and measure the same outcomes that 
were assessed at 2-years. 
 
2. Background, Rationale, and Present state of Knowledge  
 
Tears of the rotator cuff tendons are a very common entity.  Uhthoff and associates(1)  
found a 20% incidence in a series of cadaver dissections.  Lehman and associates(2)  found 
an incidence of 17% in a large series of cadaver dissections with an incidence of 30% in 
those older than 60 years of age.  Surgical repair of the rotator cuff is the preferred 
treatment with failure of conservative therapy. The results of open repair of the rotator cuff 
have shown that function and strength can be successfully restored, and that pain is 
effectively relieved.(3-6) Failure of open cuff repair can occur as a result of infection, 
failure of the deltoid muscle reattachment, and re-tearing of the rotator cuff.(7) Failure of 
the rotator cuff repair is the most frequently observed complication, and has been estimated 
between 20 and 68%. (8)   Failure of the repair of the rotator cuff may occur secondary to 
poor tendon or bone quality, failure of suture or knots, inadequate fixation of tendon to 
bone, lack of tendon to bone healing, or inappropriate postoperative care.(9-11)    
 
In the interest of minimizing the surgical morbidity associated with open rotator cuff repair, 
minimally invasive arthroscopic techniques have evolved. These techniques do not require 
detachment in the deltoid muscle, and thus deltoid detachment is not seen as a complication 
in arthroscopic cuff repair.  Advantages of the arthroscopic method include smaller skin 
incisions, glenohumeral joint inspection, treatment of intra-articular lesions, and more rapid 
rehabilitation.(12) Weber and associates have shown that the rate of infection seen in 
arthroscopic cuff repair is lower than that of open repair:  failure of the repair itself however 
does occur with arthroscopic methods.(13)  Various reports have shown that a correlation 
exists between the anatomical integrity of the cuff as determined by various imaging 
modalities and the functional outcome following open repair.(5, 6, 14)  

 
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According to Gerber et al.(10), the principles of successful repair include strong tissue 
grasping, strong repair to bone, and little gap formation until healing.  The two most 
popular methods of achieving these goals using arthroscopic technique involve the use of 
suture anchors, either in a single row or double row configuration.  
 
Studies that examine pull-out strength allow for comparison of different techniques with 
respect to the strength of initial repair.  However, as healing occurs, the repaired tendon 
relies less and less on initial fixation and more greatly on the innate strength of the tendon-
bone junction.  It is possible that a greater area of contact between the healing tendon and 
bone may result in increased strength.  The surface area provided by different types of 
repairs has been studied by Apreleva et al.(15)  The authors quantitatively studied the 3-
dimensional area of the original supraspinatus insertion and compared this area to four 
different methods of reconstruction, in 10 human cadavera.  The methods included 
transosseus simple suture, transosseous mattress suture, suture-anchor simple suture, and 
suture-anchor mattress suture.  The authors concluded that transosseus simple suture 
reproduced the greatest area at 85% original surface area, and that the other three methods 
reproduced 67% of the original area only.  If the anatomic rotator cuff insertion area not 
reproduced, results are likely to vary depending on the bone quality at the insertion site.   
This data has been used as the justification for adding a double row to arthroscopically 
repaired rotator cuffs.(16) 
 
Dugas et al.(17) determined the insertion area of the rotator cuff tendons.  The mean area of 
the supraspinatus insertion was 1.55 cm2.  The mean medial-to-lateral and anterior-to-
posterior dimensions were 1.27 cm and 1.63 cm respectively. 
 
In an effort to maximize contact area, the double row technique was described by Lo et 
al.(16)  The first row is placed medially and sutures are threaded through the rotator cuff 
using mattress technique.  The second lateral row is placed further laterally on the footprint.  
The authors suggest that a greater number of points of fixation and improved coverage may 
improve results. 
 
Pullout strength of suture anchors has been shown to correlate with trabecular and cortical 
bone mineral density.(18)  Load to failure was found to be greatest in the middle and 
anterior regions of the proximal greater tuberosity.   However, other authors have found no 
correlation between suture anchor failure and overall bone mineral density, and higher load 
to failure with anchors in the posterior greater tuberosity.(19)  
 
Kim et al. compared single row and double row fixation on nine pairs of cadaver 
shoulders.(20)  The authors reported that double row repair demonstrated superior 
performance over single row repair.  Gap formation, strain, repair stiffness and ultimate 
load to failure was superior in the double row repair.   
 
Cummins et al. compared various configuration of suture anchors with transosseus sutures 
in an animal model.(21)  Suture anchor repair was found to be comparable to transosseus 
repair in pullout strength.  The weakest repair involved single-loaded sutures anchors 
applied through the cuff with simple stitches.  Pullout strength improved two-fold with 
mattress sutures and double-loaded suture anchors, with the strongest configuration 
involving a double-row repair with mattress sutures. 
 
Mazzocca et al. compared four arthroscopic repair techniques in 20 human cadaveric 
shoulders.(22)  The authors compared single row with three types of double row fixation:  
diamond, mattress double anchor, and modified mattress double anchor.  Footprint area, 

 
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displacement under cyclic loading and load to failure were examined.  No difference 
between single row and double row fixation was found in cuff displacement or load to 
failure.  A significantly larger cuff footprint area was found in all double row configurations 
over single row repairs. 
 
Uhthoff et al.(23) have demonstrated in a rabbit model that the portion of tendon in contact 
with the bony trough influences the quality of healing.  Fibrocartilage formed at sites where 
transected tendon was in contact with bone but not where the articular or bursal tendon 
surface contacted bone. 
 
Gartsman et al. performed a prospective, randomized study in 93 patients to investigate the 
effect of subacromial decompression on arthroscopic rotator cuff repair.(24)  The authors 
did not identify any difference between the interventions.  Overall outcome for arthroscopic 
cuff repair with and without acromioplasty was 91.5 and 89.2 respectively using the ASES 
outcome measure.   
 
In an earlier study, Gartsman et al. reported on the outcome of 73 patients with a minimum 
two year follow-up who underwent arthroscopic rotator cuff repair.(25)  The authors 
reported a statistically significant improvement in all three rating scores (Constant, ASES 
and UCLA) from preoperative outcome scores.  At final follow-up, 90% of patients rated 
their level of satisfaction as good or excellent. 
 
Boileau et al. evaluated the outcomes and anatomical results in 65 patients who underwent 
arthroscopic repair of full thickness supraspinatus tears.  The authors reported excellent by 
the outcome score of Constant in 77%, good in 15%, fair in 6% and poor in 2%.  Overall, 
88% achieved effective pain relief, and and 95% were either very satisfied or satisfied.  
MRI or CT-arthrogram was used to assess the integrity of the tendon a minimum of 6 
months after repair.  Complete healing was noted in 71% of shoulders, and partial healing in 
5%.   The incidence of tendon healing was similar with previously reported anatomical 
outcomes for open rotator cuff repair.(4-6, 26) 
 
Smith et al.36  Have demonstrated in rotator cuff repair with a double-row SutureBridge 
configuration, self-reinforcement is seen in repairs with and without medial-row knots. Self-
reinforcement is greater with the knotless technique.  
 
In a recently published retrospective study, the results of single row fixation was compared 
with double row fixation.(27)  The authors reported on 80 shoulder with a mean follow-up 
of 35 months.  The series included 39 patients who underwent repair with a single-row 
technique, and 41 patients who underwent a double-row repair.   The functional outcomes 
based on UCLA and ASES scores were not significantly different in the two techniques.  
However, the incidence of re-tear in small tears was 13% in the single-row group compared 
with no defects in the double-row group, and for large and massive tears, 44% in the single 
row and 29% in the double-row group.   
 
The principle investigator has performed bench testing to compare the surface contact area 
of the two techniques.  Single row repairs were compared with double row repairs have a 
significantly smaller surface contact area.  However, clinical evidence exists to suggest that 
the healed contact area for single repairs is similar or equal to that of double row repairs as 
healing occurs over the entire cuff footprint.(28) 
 
The authors believe it is scientifically necessary to investigate the differences between 
single-row and double-row fixation for arthroscopic rotator cuff repair.  As more surgeons 
are trained in the technique, it will be performed more frequently.  Increased patient 

 
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awareness continues to lead to increasing demand for the minimally invasive approach.  
Double-row repair brings with it an increase in operative time and a significantly increased 
cost related to implants. Furthermore, a double-row reconstruction was found to be more 
economically attractive for larger rotator cuff tears (>3cm)35.  
 
 
3. References: 
 
1. 
Uhthoff HK, Loehr J, Sarkar K, editors. The pathogenesis of rotator cuff tears. 
Proceedings of the Third International Conference on Surgery of the Shoulder; 1986; 
Fukuora, Japan. 
2. 
Lehman C, Cuomo F, Kummer FJ, Zuckerman JD. The incidence of full thickness 
rotator cuff tears in a large cadaveric population. Bull Hosp Jt Dis. 1995;54(1):30-1. 
3. 
Gerber C, Fuchs B, Hodler J. The results of repair of massive tears of the rotator 
cuff. J Bone Joint Surg. 2000;82(4):505-15. 
4. 
Liu SH, Baker CL. Arthroscopically assisted rotator cuff repair: correlation of 
functional results with integrity of the cuff. Arthroscopy. 1994;10(1):54-60. 
5. 
Harryman DT, 2nd, Mack LA, Wang KY, Jackins SE, Richardson ML, Matsen 
FA, 3rd. Repairs of the rotator cuff. Correlation of functional results with integrity of the 
cuff. The Journal of bone and joint surgery American volume. 1991;73(7):982-9. 
6. 
Gazielly DF, Gleyze P, Montagnon C. Functional and anatomical results after 
rotator cuff repair. Clin Ortho Rel Res. 1994;304:43-53. 
7. 
Matsen FA, Arntz CT, Lippitt SB. Rotator Cuff. In: Rockwood CA, Jr., Matsen 
FA, Wirth MA, Harryman DT, editors. The Shoulder. 2nd ed. Philadelphia: W.B. 
Saunders company; 1998. p. 755-839. 
8. 
Jost B, Pfirrmann CW, Gerber C, Switzerland Z. Clinical outcome after structural 
failure of rotator cuff repairs. The Journal of bone and joint surgery American volume. 
2000;82(3):304-14. 
9. 
Goutallier D, Postel JM, Bernageau J, Lavau L, Voisin MC. Fatty muscle 
degeneration in cuff ruptures. Pre- and postoperative evaluation by CT scan. Clin Orthop 
Relat Res. 1994;304:78-83. 
10. 
Gerber C, Schneeberger AG, Beck M, Schlegel U. Mechanical strength of repairs 
of the rotator cuff. The Journal of bone and joint surgery British volume. 1994;76(3):371-
80. 
11. 
Warner JP, Krushell RJ, Masquelet A, Gerber C. Anatomy and relationships of 
the suprascapular nerve: anatomical constraints to mobilization of the supraspinatus and 
infraspinatus muscles in the management of massive rotator-cuff tears. The Journal of 
bone and joint surgery American volume. 1992;74(1):36-45. 
12. 
Gartsman GM. Arthroscopic rotator cuff repair. Clin Orthop Relat Res. 
2001(390):95-106. 
13. 
Weber SC, Abrams JS, Nottage WM. Complications associated with arthroscopic 
shoulder surgery. Arthroscopy. 2002;18(2 Suppl 1):88-95. 
14. 
Thomazeau H, Boukobza E, Morcet N, Chaperon J, Langlais F. Prediction of 
rotator cuff repair results by magnetic resonance imaging. Clin Ortho Rel Res. 
1997(344):275-83. 
15. 
Apreleva M, Ozbaydar M, Fitzgibbons PG, Warner JJ. Rotator cuff tears: the 
effect of the reconstruction method on three-dimensional repair site area. Arthroscopy. 
2002;18(5):519-26. 

 
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16. 
Lo IK, Burkhart SS. Double-row arthroscopic rotator cuff repair: re-establishing 
the footprint of the rotator cuff. Arthroscopy. 2003;19(9):1035-42. 
17. 
Dugas JR, Campbell DA, Warren RF, Robie BH, Millett PJ. Anatomy and 
dimensions of rotator cuff insertions. J Shoulder Elbow Surg. 2002;11(5):498-503. 
18. 
Tingart MJ, Apreleva M, Zurakowski D, Warner JJ. Pullout strength of suture 
anchors used in rotator cuff repair. The Journal of bone and joint surgery American 
volume. 2003;85-A(11):2190-8. 
19. 
Barber FA, Feder S, Burkhart S, Ahrens J. The relationship of suture anchor 
failure and bone density to proximal humerus location:  a cadaveric study. Arthroscopy. 
1997;13(3):340-5. 
20. 
Kim DH, Elattrache NS, Tibone JE, Jun BJ, DeLaMora SN, Kvitne RS, et al. 
Biomechanical comparison of a single-row versus double-row suture anchor technique 
for rotator cuff repair. Am J Sports Med. 2006;34(3):407-14. 
21. 
Cummins CA, Appleyard RC, Strickland S, Haen PS, Chen S, Murrell GA. 
Rotator cuff repair: an ex vivo analysis of suture anchor repair techniques on initial load 
to failure. Arthroscopy. 2005;21(10):1236-41. 
22. 
Mazzocca AD, Millett PJ, Guanche CA, Santangelo SA, Arciero RA. 
Arthroscopic single-row versus double-row suture anchor rotator cuff repair. Am J Sports 
Med. 2005;33(12):1861-8. 
23. 
Uhthoff HK, Seki M, Backman DS, Trudel G, Himori K, Sano H. Tensile strength 
of the supraspinatus after reimplantation into a bony trough: an experimental study in 
rabbits. J Shoulder Elbow Surg. 2002;11(5):504-9. 
24. 
Gartsman GM, O'Connor D P. Arthroscopic rotator cuff repair with and without 
arthroscopic subacromial decompression: a prospective, randomized study of one-year 
outcomes. J Shoulder Elbow Surg. 2004;13(4):424-6. 
25. 
Gartsman GM, Khan M, Hammerman SM. Arthroscopic repair of full-thickness 
tears of the rotator cuff. J Bone Joint Surg. 1998;80(6):832-40. 
26. 
Knudsen HB, Gelineck J, Sojbjerg JO, Olsen BS, Johannsen HV, Sneppen O. 
Functional and magnetic resonance imaging evaluation after single-tendon rotator cuff 
reconstruction. J Shoulder Elbow Surg. 1999;8(3):242-6. 
27. 
Sugaya H, Maeda K, Matsuki K, Moriishi J. Functional and structural outcome 
after arthroscopic full-thickness rotator cuff repair: single-row versus dual-row fixation. 
Arthroscopy. 2005;21(11):1307-16. 
28. 
Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. 
Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really 
heal? The Journal of bone and joint surgery American volume. 2005;87(6):1229-40. 
29. 
Kirkley A, Alvarez C, Griffin S. The development and evaluation of a disease-
specific quality-of-life questionnaire for disorders of the rotator cuff: The Western 
Ontario Rotator Cuff Index. Clin J Sport Med. 2003;13(2):84-92. 
30. 
Constant CR, Murley AH. A clinical method of functional assessment of the 
shoulder. Clin Ortho Rel Res. 1987;214:160-4. 
31. 
Richards RR, Kai-Nan A, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, 
et al. A standardized method for the assessment of shoulder function. J Shoulder Elbow 
Surg. 1994;3:347-52. 
36.        Smith, G; Bouwmeester, T; and; Lam, P. Knotless double-row SutureBridge rotator 
cuff repairs       have improved self-reinforcement compared with double-row SutureBridge 
repairs with tied medial      knots: a biomechanical study using an ovine model. J Shoulder 
Elbow Surg. 2017.06.045  
 

 
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4.  Research Design, Methods and Analysis 
 
Primary research question 
Do patients who underwent rotator cuff repair with arthroscopic technique using single row 
fixation have improved disease specific quality of life, as measured by the Western Ontario 
Rotator Cuff Index (WORC) at 8 years post-operatively compared with double row fixation.   
 
Secondary Research Questions 
1) What is the difference in anatomical outcome between double and single row fixation, 
as measured by US or MRI, at 8 years post-operative? 
2) What is the difference in outcome as measured by the Constant score, and the ASES 
score, at 8 years post-operative? 
 
Response variables 
Our primary outcome measure is the disease specific Western Ontario Rotator Cuff Index 
(WORC)(29). The secondary outcome measures are the Constant Score(30), the American 
Shoulder and Elbow Society standardized assessment of shoulder function (ASES)(31). US or 
MRI evaluations will be carried out at 8 years post-operative to determine the healing status of 
the rotator cuff.   
 
Null Hypothesis  
There will be no significant differences in functional or quality-of-life outcomes (WORC 
scores) in patients who underwent  single-row compared to  double-row fixation techniques.   
 
Why is a trial needed now? 
As soft-tissue healing can be considered to be complete by twelve months, it seems likely that 
any further changes in healing status would be related to chronic intrinsic tendon pathology, 
which should be similar between groups. However, it is important to know the long-term results 
in terms of pain, function, strength, and patient satisfaction.  
 
Give references to any relevant systematic review and discuss the need for your trial in the 
light of these reviews 
An advanced search of the clinical database in Medline was undertaken. 
There have been no systematic reviews or comparative studies and only a handful of case series. 
Favorable long-term results of case series have been reported demonstrating the efficacy of both 
single row and double row techniques.  Hence the need for a randomized controlled trial 
comparing the two different types rotator cuff fixation.   
 
How will the results of this trial be used? 
The results of the trial will provide valuable information regarding the best technique for 
managing the rotator cuff via arthroscopic repair.  The data obtained from quality of life 
measurements will enable the authors to suggest recommendations that will lead to maximizing 
function and quality of life in patients undergoing arthroscopic rotator cuff repair.  The 
information will be presented at national and international shoulder meetings, and publications 
will be sought in major orthopaedics journals.   
 
 
4.1 THE PROPOSED TRIAL 
 
What is the proposed trial design? 
Long term follow-up of a multicentred, randomized trial. 
 
4.2 What are the planned trial interventions? 

 
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All patients have undergone a standard diagnostic arthroscopy using either single-row or 
double row fixation.   
 
Single row fixation: 
Single row fixation is defined as follows:  fixation by way of bone anchors, located along a 
single row parallel to the sagittal axis of the rotator cuff footprint.  The exact location of the 
anchors may occur either within that lateral margin of the footprint, or lateral to the 
footprint, over the edge of the tuberosity.  Either simple or mattress sutures were used at the 
discretion of the surgeon.    
 
Double row fixation: 
Double row fixation is defined as follows:  fixation by way of bone anchors, located along 
two rows.  The lateral row is parallel to the sagittal axis of the rotator cuff footprint.  The 
exact location of the anchors occurred either within that lateral margin of the footprint, or 
lateral to the footprint, over the edge of the tuberosity.  Either simple or mattress sutures 
were used at the discretion of the surgeon.   The medial row is parallel to the sagittal axis of 
the rotator cuff footprint.  The exact location of the fixation occurred close to the 
bone/cartilage junction along the medial aspect of the footprint.  Mattress sutures were used.  
An acceptable alternative method of fixation for the medial row consists of the Suretak II 
(Smith and Nephew).  This device consists of a sutureless bioabsorbable implant and 
anchors the rotator cuff to the bone.  
 
4.4 What are the proposed methods for protecting against sources of bias?  
Blinding: Due to the nature of this surgical trial, the surgeon could not be blinded to the 
intervention. However, a trained independent assessor will carry out the follow-up 
assessments and will be blinded.  This will minimize the potential for biases introduced by 
the examiner when performing the physical assessment and recording data.   The assessor 
will not have access to the patient chart prior to the examination.  The patient will also be 
blinded to the treatment assignment.  To help reduce the potential for observer bias, the 
physical examination and the administration of study questionnaires are standardized.  
 
4.5 What are the planned inclusion/exclusion criteria? 
 
Patient Population 
The target population is both men and women of any age that were randomized in the original 
double versus single row RCT.   
 
 
 
 
 
Inclusion Criteria  
1. Randomized in the double versus single row original RCT study  
Exclusion Criteria   
1. Excluded from the original study 
2. Withdrew from original Study  
3. Unable or unwilling to provide informed written consent 
 
4.6 What is the proposed duration of treatment period?  
All patients will come in for one clinic visit and will not be followed any further after all of 
the imaging and clinic data has been collected. 
 
4.7 What is the proposed frequency and duration of follow-up? 
Patients are assessed in the clinic by the blinded evaluators at 8 years post operatively. It is 
anticipated that at this clinic visit approximately 20 minutes will be spent with the assessor. 

 
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However, as in all doctors’ clinics, some waiting can be anticipated and this can be variable 
depending on clinic loads and nature of cases. 
 
Radiographic analysis will be done with an ultrasound or MRI at 8 years postoperative.  
Evaluation of the imaging will be performed by an independent investigator who is blinded 
to the patient’s assigned treatment.   
 
 
 
4.8 What are the proposed primary and secondary outcome measures? (see Appendix 
A) 
PRIMARY:  
The Western Ontario Rotator Cuff Index (WORC)(29) is a disease specific evaluation that 
has proven to be an accurate and valid assessment of function after rotator cuff repair. Because 
it is specific for rotator cuff disease of the shoulder, it is highly sensitive to small but clinically 
significant changes in patient function. 
 
SECONDARY: 
1)  The American Shoulder and Elbow Surgeon’s (ASES) score is a shoulder specific 
assessment tool developed by the American Shoulder and Elbow Society for use in all types 
of shoulder problems (Appendix A)(31).  It consists of both patient self-assessment and 
physician assessment.  The patient self-evaluation is divided into two sections: pain and 
activities of daily living (ADL). Pain is recorded on a visual analogue scale and ADL’s are 
recorded on a numeric scale. The overall score is an equal weight of the two sections and 
produces a score out of 100. The higher the score, the better the outcome.  The physician 
assessment is divided into four segments: range of motion, physical signs, strength and 
instability. The results of the physician assessment do not provide a score. 
 
Europeans favor the Constant Score(30) (Appendix A).  It has been validated, normalized in 
comparison to disease free patients and places greater emphasis on range of motion and 
strength The European shoulder society has adopted the Constant Score for functional 
assessment of the shoulder.  The Constant Score records a variety of shoulder measurements 
including an objective test of strength using a spring loaded measuring device. The 
Constant Score reflects an overall clinical functional assessment.  This instrument is based 
on a 100-point scoring system calculated from a self-assessment portion that evaluates pain 
and ability to perform tasks of daily living, and a clinical assessment which tests active 
range of shoulder motion and strength.  The higher the score the better the outcome. 
 
2) Further secondary outcomes which will be monitored during the post-operative course 
include: operative times of the two procedures, complications, and the incidence of revision 
surgery in each procedure. 
 
The MRI or Ultrasound will determine the healing rates of both procedures.  It is imperative 
to determine the relative healing rates as cuff integrity following surgery correlates with 
function and strength.   
 
 
 
 
 
4.9 How will the outcome measures be measured at follow-up? 
PRIMARY: 
The patient will complete the WORC questionnaire at 8 years post-operatively. The research 
assistant will be available to answer any questions.  
 
SECONDARY: 
1)  Patients will complete the ASES and Constant Scores at 8 years post-operatively. The 
research assistant will be available should the patient have any questions regarding the 
questionnaires. The patient is then examined by the blinded assessor for the physical 

 
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assessment portion of the constant score (Appendix A). The surgeon is the last person to 
examine the patient and is blinded to the results of the outcomes. 
 
4.10 Details of planned analyses 
Primary:  
The primary analysis involves a comparison of the mean WORC scores between the two 
surgical treatment groups. This analysis is a two sample independent t-test to assess whether 
there is a statistically significant difference between groups for the mean WORC scores at 8 
years post-operatively. The 5% significance level is employed.  The underlying assumption for 
the WORC 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 will be performed.  
 
Secondary:  
The secondary analysis involves a comparison of the secondary outcome measures between the 
two surgical treatment groups. The ASES, Constant Score, and imaging healing rates will be 
analyzed for differences between the two groups at 8 years. The planned secondary analyses 
are performed using a 5% significance level.  No p-value adjustment is required for multiple 
outcomes, as treatment effectiveness is based only on the primary variable. 
 
 
4.12 What is the proposed frequency of analyses?  
The analysis will occur once all eligible patients have been recruited and all patient data has 
been collected.  
 
4.13 What is the estimated cost and duration of the trial? 
The duration of this trial will be 1 year.   This study does not have any direct costs. 
 
DETAILS OF TRIAL TEAM 
Trial management: 
 
What are the arrangements for day to day management of the trial?  
The orthopedic research study coordinator is responsible for the day to day management of the 
trial.  This includes: general administrative details, collecting, monitoring, tracking and 
analyzing data. The Study Research Coordinator (SRC) has experience in biostatistics, 
computer technology, epidemiology and study management. He/she is available to answer 
questions on a daily basis. Quality Monitoring: Forms: All forms are checked by the SRC for 
completeness, consistency and extreme values. Appointments: The SRC is responsible for 
monitoring participant visits Equipment: The scales used to measure power are calibrated. 
Data Management: is supervised by the study biostatistician. Data is collected on standardized 
Case Recording Forms (CRF).  Any revisions to the CRF’s are dated to maintain an audit trail 
of these changes.  CRF’s are signed and dated by the clinical investigator.  
 
 
 

 
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5.  APPENDICES 
 
Appendix A:  Outcome Measures 
 
 
 
 
 
 
 
 
 
 
 
 
WESTERN ONTARIO 
 
ROTATOR CUFF INDEX 
 
(WORC)© 
 
 
 
 
 
 
 
A disease-specific quality of life measurement tool for patients 
with rotator cuff disease 
 
 
 
Patient Initials:___________ 
 
 
 

 
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            Copyright © 1998 (#474673) A. Kirkley MD, S. Griffin, CSS, C. Alvarez, MD 
INSTRUCTIONS TO PATIENTS 
 
 
In the following questionnaire you will be asked to answer questions in the 
 
following format and you should give your answer by putting a slash "/" on the  
           horizontal line. 
 
 
NOTE: 
 
 
1. If you put a slash "/" at the left end of the line i.e. 
 
 
 
 
 
    then you are indicating that you have no pain. 
 
 
 
2. If your put your slash "/"  at the right end of the line i.e.


 
 
   then you are indicating that your pain is extreme. 
 
 
 
3. Please note:  
 
 
a) that the further to the right you put your slash "/", the   
 
 
 
    more you experience that symptom. 
 
 
 
b) that the further to the left you put your slash "/"  , the less you  
 
    experience that symptom. 
 
 
c) please do not place your slash "/"  outside the end markers 
 
 
You are asked to indicate on this questionnaire, the amount of a symptom you 
have experienced in the past week as related to your problematic shoulder. If  
you are unsure about the shoulder that is involved or you have any other  
questions, please ask before filling out the questionnaire. 
 
 
If for some reason you do not understand a question, please refer to the   
           explanations that can be found at the end of the questionnaire. You can then  
           place your slash "/"  on the horizontal line at the appropriate place. If an item 
           does not pertain to you or   you have not experienced it in the past week,   
           please make your “best guess” as to which response would be the most 
           accurate. 
 
 
 
 
 
 
 
 
 
 

 
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WORC 
Section A: Physical Symptoms 
INSTRUCTIONS TO PATIENTS 
 
 
The following questions concern the physical symptoms you have 
experienced due to your shoulder problem. In all cases, please enter the 
amount of the symptom you have experienced in the last week. (Please mark 
your answers with a slash "/") 
 
 
1. 
How much sharp pain do you experience in your shoulder?  
 
 
 
no 
 
 
 
 
 
 
 
 
extreme 
 
pain 
 
 
 
 
 
 
 
 
pain 
 
 
 
 
 
 2.  
How much constant, nagging pain do you experience in your shoulder?   
 
 
no 
 
 
 
 
 
 
 
 
extreme 
 
pain 
 
 
 
 
 
 
 
 
pain 
 
 
 
3.  
How much weakness do you experience in your shoulder?  
 
 
 
no 
 
 
 
 
 
 
 
 
extreme 
 
weakness  
 
 
 
 
 
 
 
weakness  
 
 
 
4. 
How much stiffness or lack of range of motion do you experience in your 
shoulder? 
 
 
 
 
no 
 
 
 
 
 
 
 
 
extreme 
 
stiffness  
 
 
 
 
 
 
 
stiffness 
 
 
 
5. 
How much are you bothered by clicking, grinding or crunching in your 
shoulder? 
 
 
 
 
 
none 
 
 
 
 
 
 
 
 
extreme  
 

 
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Version January 24th, 2018  
 
 
 
 
6. 
How much discomfort do you experience in the muscles of your neck 
because of your shoulder? 
 
 
no 
 
 
 
 
 
 
 
 
    extreme 
 
discomfort 
 
 
 
 
 
 
 
    discomfort         
 
 
 
 
 
WORC 
SECTION B: Sports/Recreation 
 
 
 
 
INSTRUCTIONS TO PATIENTS 
 
 
 
 
 
The following section concerns how your shoulder problem has affected your 
sports or recreational activities in the past week. For each question, please 
mark your answers with a slash "/". ) 
 
 
7. 
How much has your shoulder affected your fitness level? 
 
 
not 
 
 
 
 
 
 
 
 
extremely 
 
affected  
 
 
 
 
 
 
 
affected  
 
 
 
 
8. 
How much difficulty do you experience doing push-ups or other 
strenuous  
shoulder exercises because of your shoulder? 
 
 
no 
 
 
 
 
 
 
 
 
extreme 
 
difficulty  
 
 
 
 
 
 
 
difficulty  
  
 
 
 
9. 
How much has your shoulder affected your ability to throw hard or far? 
 
 
 
 
 
not 
 
 
 
 
 
 
 
 
extremely 
 
 
affected  
 
 
 
 
 
 
 
affected 
 
 
 
 
 
 

 
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Version January 24th, 2018  
10. 
How much difficulty do you have with someone or something coming in 
contact with your affected shoulder? 
 
 
no 
 
 
 
 
 
 
 
 
extremely 
 
fear 
 
 
 
 
 
 
 
 
fearful 
 
WORC 
SECTION C: Work 
INSTRUCTIONS TO PATIENTS 
 
The following section concerns the amount that your shoulder problem has 
affected 
your work around or outside of the home. Please indicate the appropriate 
amount for the 
past week with a slash "/". 
 
 
   11. 
 
How much difficulty do you experience in daily activities about  
  
 
 
the house or yard? 
 
 
 
no 
 
 
 
 
 
 
 
 
extreme 
 
 
difficulty  
 
 
 
 
 
 
 
difficulty  
 
 
 
 
 12. 
 
How much difficulty do you experience working above your 
shoulder? 
 
 
 
no  
 
 
 
 
 
 
 
 
extreme 
 
 
difficulty  
 
 
 
 
 
 
 
difficulty  
 
 
 
 
13. 
How much do you use your uninvolved arm to compensate for 
your injured one?  
 
 
 
not at 
 
 
 
 
 
 
 
 
constant  
 
 
all 
 
 
 
 
14. 
How much difficulty do you experience lifting heavy objects at or 
below shoulder level? 
 
 
 
no 
 
 
 
 
 
 
 
 
extreme 

 
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Version January 24th, 2018  
 
 
difficulty  
 
 
 
 
 
 
 
difficulty 
 
 
 
 
 
 
 
WORC 
SECTION D: Lifestyle 
INSTRUCTIONS TO PATIENTS 
 
The following section concerns the amount that your shoulder 
problem has affected or changed your lifestyle. Again, please indicate 
the appropriate amount for the past week 
with a slash "/". 
 
 
 
        15. 
How much difficulty do you have sleeping because of your 
shoulder?  
 
 
 
 
 
no  
 
 
 
 
 
 
 
 
extreme 
 
 
difficulty  
 
 
 
 
 
 
 
difficulty  
 
 
 
 
 
16. 
How much difficulty have you experienced with styling your hair 
because of your shoulder? 
 
 
 
no 
 
 
 
 
 
 
 
 
extreme 
 
 
difficulty  
 
 
 
 
 
 
 
difficulty 
 
 
 
 
 
 
17. 
How much difficulty do you have  “roughhousing or horsing 
around” with family or friends? 
 
 
 
no 
 
 
 
 
 
 
 
 
extreme 
 
 
difficulty  
 
 
 
 
 
 
 
difficulty  
 
 
 
 
 

 
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Version January 24th, 2018  
         18. 
How much difficulty do you have dressing or undressing? 
 
 
 
no 
 
 
 
 
 
 
 
 
extreme 
 
 
difficulty  
 
 
 
 
 
 
 
difficulty 
 
 
 
 
 
 
 
 
 
WORC 
 
 
 
 
 
SECTION E: Emotions 
INSTRUCTIONS TO PATIENTS 
 
The following questions relate to how you have felt in the past week 
with regard to your shoulder problem. Please indicate your answer 
with a slash "/". 
 
   
 
 
 
19. 
How much frustration do you feel because of your shoulder? 
 
 
 
no 
 
 
 
 
 
 
 
 
extreme 
 
 
frustration 
 
 
 
 
 
 
 
frustration 
 
 
 
 
 
20. 
How  “down in the dumps” or depressed do you feel because of 
your shoulder? 
 
 
 
none 
 
 
 
 
 
 
 
 
extreme 
 
 
 
 
21. 
How worried or concerned are you about the effect of your 
shoulder on your occupation? 
 
 
 
not at 
 
 
 
 
 
 
 
 
extremely 
 
 
all 
 
 
 
 
 
 
 
 
concerned 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Version January 24th, 2018  
 
 
 
 
 
 
 ______________________________________________________________________
 ______________________________________________________________________
 ______________________________________________________________________ 
 
 THANK YOU FOR COMPLETING THE QUESTIONNAIRE 
 
 
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form 
(ASES): Patient Self-Report Section 
 
1. Pain: 
 
 
How bad is your pain today?   (mark an “X” on the line) 
 
 
 
|_______________________________________________| 
 
 
 
No pain at all  
 
 
 
 
 
Pain as bad 
 
 
 
 
 
 
 
 
 
 
as it can be 
2. Satisfaction: 
Overall, what is your level of satisfaction with your shoulder? 
 
 
 
|_______________________________________________| 
 
 
 
 
Poor 
 
 
 
 
 
 
 
Excellent 
 
 
 
3. Function:  Circle the number in the box that indicates your ability to do the following 
activities: 
 
0 = Unable to do;   1 = Very difficult to do;   2 = Somewhat difficult;   3 = Not difficult 
 
 
Activity  
 
 
 
Right arm 
 
 
Left arm 
1. Put on a coat 
 
 
 
0    1    2    3  
 
0    1    2    3 
2. Sleep on your painful or affected side 0    1    2    3  
 
0    1    2    3 
3. Wash back/do up bra in back 
 
0    1    2    3  
 
0    1    2    3 
4. Manage toileting  
 
 
0    1    2    3  
 
0    1    2    3 
5. Comb hair 
 
 
 
0    1    2    3  
 
0    1    2    3 
6. Reach a high shelf 
 
 
0    1    2    3  
 
0    1    2    3 
7. Lift 10 lbs. above shoulder 
 
0    1    2    3  
 
0    1    2    3 

 
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Version January 24th, 2018  
8. Throw a ball overhand  
 
0    1    2    3  
 
0    1    2    3 
9. Do usual work – List:_____________ 0    1    2    3  
 
0    1    2    3 
10. Do usual sport – List: _____________ 0    1    2    3  
 
0    1    2    3 
 
 

 
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Version January 24th, 2018  
 
 
CONSTANT SCORE 
 
 
Dominance 
   left                         right 
Affected side 
   left              right
Normal side 
   left               right
Pain 
 
 
 
severe 0, moderate 1-5, mild 6-10, none 11-15
 
/ 15
 
/  15
Activities of Daily Living 
 
 
Work  
0 (unable) – 4 (full w/o restriction)
 
/  4
 
/  4
Recreation/sport 
0 (unable) – 4 (full activities)
 
/  4
 
/  4
Sleep 
0 (grossly disturbed) – 2 (undisturbed)
 
/  2
 
/  2
 
 
Ability to work at the level: 
             (check one) 
 
_____ none 
_____ waist 
_____ xyphoid 
_____ neck 
_____ head 
_____ above head
_____ none 
_____ waist 
_____ xyphoid 
_____ neck 
_____ head 
_____ above head
Motion (passive) 
Forward flexion / elevation
                 Degrees
                   Degrees
Abduction
                 Degrees
                   Degrees
ER
                 Degrees
                   Degrees
IR
             ______ Level
                ______ Level
Motion (active) 
Hand behind head (elbow forward)
Yes  /  No
Yes  /  No
Hand behind head (elbow back)
Yes  /  No
Yes  /  No
Hand on head (elbow forward)
Yes  /  No
Yes  /  No
Hand on head (elbow back)
Yes  /  No
Yes  /  No
Full elevation from top of head
Yes  /  No
Yes  /  No
Active motion 
 
 
 
Dorsum of hand to: 
       (check one) 
____ lateral thigh
 
 
(0)
 
ER
 
__ hand behind head with 
elbow held forward
 
(2) 
____  buttock
 
 
 
(2)
 
 
__ hand behind head with 
elbow held back
 
(2) 
____  lumbosacral junction 
____  waist 
____  12th dorsal vertebra 
____  interscapular region (T7)
 
 
 
____ lateral thigh
 
 
(0)
 
ER
 
__ hand behind head with 
elbow held forward
 
(2) 
____  buttock
 
 
 
(2)
 
 
__ hand behind head with 
elbow held back
 
(2) 
____  lumbosacral junction 
____  waist 
____  12th dorsal vertebra 
____  interscapular region (T7)
 
 
Power 

 
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Version January 24th, 2018  
1.  trial
Lb
Lb
2.  trial
Lb
Lb
3.  trial
Lb
Lb