Ellis Developments Limited

Nottinghamshire, United Kingdom

An Embroidered Polyester Augmentation Device

in the Treatment of Large or Massive Rotator Cuff Tears

In-Ho Jeon MD*, Jeyam M, Roy B, Ellis J OBE,

Lars Neumann FRCS (Ed), W. Angus Wallace, FRCS, FRCS Ed (Orth)

Nottingham Shoulder and Elbow Unit, Nottingham, UK, *Department of Orthopaedic Surgery, Kyungpook National University, Daegu, Korea,

 

Background: Various surgical treatments for large or massive rotator cuff tear are reported in the literature, but the clinical results are variable.

 

Purpose: To report the clinical results of reconstructing large or massive rotator cuff tears by using an embroidered polyester augmentation device.

 

Study Design: Case series

 

Methods: Fifty consecutive patients were included in the study. There were 28 men and 22 women with an average age of 64 years (range: 45- 75 years). The shoulder function was assessed by Constant and Murley score. Insertion involved anchoring the device to the undersurface of the retracted rotator cuff with Ethibond sutures, passing the other end of the device through a bone tunnel under the greater tuberosity and anchoring the device, under tension, to the proximal humerus with 1 or 2 screws.

 

Results: The overall Constant score improved from 33.1 preoperatively to 57.2 postoperatively (p=0.05). In the large size tear group (n=14), the overall Constant score improved from 27.2 to 50.64. In the massive tear group (n=36), it improved from 35.4 to 60.0. However, there was no statistically significant difference between the two groups in terms of improvement of Constant score (p=0.05). Two had MRI confirmed re-rupture, and one shoulder required manipulation and arthroscopic arthrolysis. No patient in this series developed infection.

 

Conclusion: Polyester augmentation device for the reconstruction of large or massive rotator cuff tears provided a satisfying procedure in this complex and challenging group of patients.

 

Keywords: large, massive, rotator cuff tear, polyester augmentation device

 

Introduction

Although rotator cuff surgery has evolved, reconstruct of the massive rotator cuff tears is still challenging problem for orthopedic surgeons. 15,17 Because, there is very little chance of spontaneous natural healing of large, massive tears of rotator cuffs, various treatments have been reported for these tears, which include simple decompression with debridement,5,12,25 tendon transfer, 3,27 partial repair with margin convergence 6 and primary repair with various augmentation devices 4,18,24 or allograft.22-24 Simple decompression and debridement can provide early recovery with good pain relief but the long term results are not promising especially in high demand shoulders. 5 Tendon transfer is not always indicated because of the radical nature of such surgery. 25 Open repair by transosseous sutures has been a standard approach with good results in more than 85% of patients. 8 However, rotator cuff tissue in large or massive tears is retracted and very friable especially in elderly patients. Thus, re-rupture of primary repair in large or massive rotator cuff tears is reported 60-70%.14,17 Biomechanical studies in the rotator cuff repair have shown the predominant mode of failure in rotator cuff surgery has been suture migration through bone associated with failure of the bone at lower tensile loads than the suture in the osteoporotic greater tuberosity. 1,4,7,15,19 Various methods of soft tissue fixation to the bone have been proposed such as anchor screws, staples and screws. In addition, augmentation devices such as absorbable plates 20 or metal screws, plate have been proposed to better fixation of the sutures to the bone.

With the experience of an embroidered flexible device used in the shoulder arthroplasty in cuff arthropathy, authors hereby applied this embroidered polyester device (Nottingham augmentation device, Pearsalls, Somerset) in the large or massive rotator cuff repair. The purpose of this study is to describe the use and application of an embroidered polyester cuff reinforcement device for the treatment of large or massive rotator cuff tears and review the functional results.

Materials and Methods

Study Groups

From January 2002 to September 2005, 50 consecutive patients underwent repair of massive or large size rotator cuff tears via the embroidered polyester augmentation device technique.

There were 28 male and 22 female patients included in the study. The mean age of the patients at the time of surgery was 64 years (range, 45-78 years). Thirty-one right shoulders and 19 left shoulders were affected.

Inclusion criteria were patients who had clinical weakness and pain with a large or massive full thickness tear confirmed during the surgery. Indications for this device were for patients with poor quality of the tendon or the bone which would not normally allow direct repair. A Senior surgeon performed the surgery throughout the study.

Tears were described as massive if two or more tendons were involved, and they were deemed irreparable if after both anterior release of the rotator interval and posterior release of the supraspinatus and infraspinatus tendons, a tension-free repair could not be obtained. The definition of the large size tear was a tear diameter of over 5cm.

Operative Technique

The procedure could begin with an arthroscopic evaluation of the glenohumeral joint to rule out smaller size tear, otherwise a straight anterolateral skin incision was made. The rotator cuff is approached via an anterolateral deltoid split with detachment of the adjacent deltoid sub-periosteally leaving an adequate amount of good quality tissue to allow a strong reattachment. The rotator cuff is temporarily held with stay sutures along its free edge and mobilised and released as much as required both at the bursa and articular sides in order for the tendon to be brought into direct contact with the bone (Figure 1). A bony trough is created at the insertion point of the tendon. Either drills or a high speed dental burr can be used to create a fan-shaped, flat tunnel emerging laterally on the proximal humerus approximately 30mm distal to the top of the greater tuberosity. The device size is chosen according to the width of the defect but it does not have to cover the full width of the tear. The device can be attached to the articular side of the tendon but the bursal side is also possible. At least two rows of sutures with a minimum of ten stitches, which include three Mason-Allen sutures in each row, are placed along the free edge of the tendon grasping sufficient tissue to provide a good hold (Figure 2). The integral introducing leader is used to pass the free end of the device through the tunnel and out onto the lateral surface of the humerus. The augmentation device is tensioned to bring the tendon into the bony trough and the appropriate fixation hole is selected in the main section of the device. Trial reduction is carried out in order to select the site of the bi-cortical fixation screw ensuring that the final reduction will allow the arm to rest at the side of the body. Once the site has been selected, access can be improved by abducting the arm. A 3.2mm diameter pilot hole is drilled, measured and tapped and the distal end of the device is secured in place with a single, fully threaded 4.5mm diameter cortical bone screw (Figure 3). As soon as the screw has securely engaged in the bone all of the device, distal to the selected fixation hole should be cut off and discarded. Following reduction and fixation of the screw, the arm should go down along the side easily. The proximal fixation is similar to “spot-welding” while the distal fixation is a “flexible plate” fixation.

Rehabilitation

All patients followed same rehabilitation protocol that was specific to the size of their tears. Postoperatively, patients were placed in an abduction pillow. Passive range-of-motion exercises were introduced by the same physical therapist two days postoperatively.

Functional status was evaluated before and after surgery in all 50 patients. The postoperative evaluation was done after 12 months in 20 patients and between two to three years in 30 patients. The symptoms were assessed by an interview and all patients were examined by the same orthopaedic surgeon. The shoulder function was assessed by Constant and Murley score; each categories of pain, activity of daily living, range of motion and abduction power were recorded. SPSS Win. ver. 12.0 is used for all statistical analysis with significance level of 0.05.

Results

Functional Outcome

All fifty patients were available for review, with a mean follow up of 31.3 months (range, 12-48 months). Table 1 summarizes the functional results. All four components of Constant score showed statistically significant functional improvement. The mean pain score improved from 7.2 ±4.3 preoperatively to 11.7 ±3.5 postoperatively. Activities of daily living score improved from 7.1 ±3.2 preoperatively to 13.2 ±5.4 postoperatively. Range of motion score improved from 16.7 ±8.6 to 26.6 ±12.0. Muscle strength measurements were assessed using the Nottingham Mecmesin myometer. Mean power also improved from 2.27 ±3.6 to 5.6 ±6.2. The overall Constant score improved from 33.1 preoperatively to 57.2 postoperatively.

Functional outcome was analyzed based on tear size. In the large size tear group (n=14), the overall Constant score improved from 27.2 preoperatively to 50.64 postoperatively. In the massive tear group (n=36), it improved from 35.4 preoperatively to 60.0 postoperatively. However, there was no statistical significant differences in the improvement of Constant score between the two groups (P=0.89). (Table 2)

Base line characteristics were analyzed based on tear size. The mean age of the large size tear was 62.3 years (n=14) and it was 64.5 years in massive tear (n=36). There was no statistically significant difference between the two groups in terms of preoperative activities of daily living, range of movement and power of the Constant score except the pain score (Table 3).

Operative findings

None of the patients in this series had a small size tear (<1cm) or medium size tear (1-3cm). Fourteen had large tears, and 36 had massive tears. The tear was large U-shaped in most of patients (n=38) and the tear was L-shaped in twelve patients. Thirty patients had an adjacent rupture of the long head of biceps, which required tenodesis to the bicipital groove.

Radiographic Evaluation

Preoperative and follow up radiographs were reviewed. There were no patients who had progression of superior migration of the humeral head except two patients with re-rupture. There were no patients who displayed any signs of bone erosion in the proximal humerus or acromion.

Complications

No intraoperative complications were noted at the time of surgery. Specific attention was focused on the operative site where no abnormal swelling, tenderness, erythema, or sinus formation throughout the recovery process. There were no deep infections.

Two had re-rupture of rotator cuff which was confirmed by clinical examination and MRI. The rupture occurred at the junction between the device and distal stump of the tendon. Three patients had a stiff shoulder after the operation. Among them, one patient required manipulation under anesthesia and arthroscopic release of capsulitis. The arthroscopy of the glenohumeral joint showed healing of the tendon to the anatomic footprint of cuff insertion. Inspection of the subacromial space demonstrated restoration of tendon continuity with complete healing of the tendon to bone interface. The arthroscopic evaluation revealed a tendon-like structure, similar in appearance to the normal supraspinatus tendon. The tendon to polyester interface also presented with good soft tissue ingrowth without failure or excessive scar formation (Figure 4)

 

Discussion

Although multiple treatment modalities are proposed in the literature, there are no widely accepted consensus treatment options for massive irreparable rotator cuff tears.

Subacromial decompression and rotator cuff debridement with or without acromioplasty has been reported to provide reasonable clinical results,12,25 these results however are inferior to those reported when massive tears could be repaired5. Several authors reported on the use of tendon transfer to facilitate reconstruction of irreparable rotator cuff tears. 2,27 Tendon transfer has proven to be a valuable technique in young, active patients. However, for most elderly patients with degenerative massive cuff lesions, there are few reliable surgical alternatives.

Polyester grafts were described as tendinous glenoid that functions to steer the humeral head on the glenoid and permits the deltoid to work effectively. 18 That polyester graft has to perform its function as a passive spacer. 24 The polyester augmentation device in our study, however, is not a graft patch to cover the tendon defect, but an augmentation anchoring device of the tendon to the bone.

A major concern after rotator cuff repair is the increasing number of reported failures in cases of large or massive tears. The failure rate has been reported to be between 38% and 65% in primary repairs. 11, 13, 16, 26 The hypovascular rotator cuff tendon limits spontaneous healing, which leads to degenerative tendon tissue with poor tissue quality, creating difficulties in achieving secure fixation. To improve success in rotator cuff repair, either a stronger, more secure initial construct must be developed.

Suture anchor fixation for rotator cuff repairs has gained popularity in recent years. The advantages of suture anchors over the bone tunnel method have been reported, however, several failure modes were described such as suture anchor pull out, soft tissue failure at suture tendon junction, and suture breakage at the anchor eyelet. 10 Ahmad et al1 presented in their biomechanical study that the suture anchor places the tissue in the proximity of the footprint with limited area of fixation, although the transosseous technique compresses the tendon to the footprint, creating a broad contact area.

Osteoporosis of the greater tuberosity is often encountered in shoulders that have  long-standing rotator cuff tears. A decreased bone density of the greater tuberosity of the head in full thickness cuff tears may compromise the results of rotator cuff repair, as it influences the holding power of suture anchors and of transosseous suture repairs.

In the Meyer et al cadaver study, bone density was higher below the articular surface than in the greater tuberosity. 21 Tendon tears were associated with a reduction in cancellous bone density over 50%. Their results suggested a deep trough should be avoided to achieve reliable tendon bone healing

This embroidered polyester augmentation device basically uses a transosseous technique for fixation, but the screws holding the device and tendon construct was fixed distal to the greater tuberosity, which could avoid a potential failure area of transosseous sutures.

Cuff repair with augmentation with a Gore-Tex patch for large rotator cuff tears were reported by Hirooka et al18 and they presented the average JOA (Japanese Orthopaedic Association) score improved from 57.7 to 88.7 at a mean of 44 month follow up. Audenaert et al3 reported synthetic interposition graft (8 layer of Mersilene mesh) in 41 massive cuff tears and the mean Constant and Murley score improved from 25.7 to 72.1 postoperatively. Only three of 41 patients presented re-tear between mesh and the supraspinatus musculotendinous junction unit. In our current study of 50 patients, the functional results were comparable with those reports. When the massive tear group was compared to the large tear group, all clinical categories of Constant score in both groups were equally improved significantly after reconstruction (p=0.05). The only difference was the improvement of pain score in the massive tear group compared to large tear group (3.8 versus 6.3).

This device was relatively resistant to re-tears in our study and integrates well with re-centering of the humeral head which had been superiorly displaced preoperatively.

We had only two re-ruptures of the rotator cuff which occurred at the junction between the device and distal stump of the tendon. At revision surgery, the device was stable at bony anchorage and there was no significant synovitis or adverse inflammatory reactions found.

We used this embroidered polyester device in the cuff arthropathy combined with hemiarthroplasty. When the retrieved polyester devices were examined under light microscopy, it demonstrated it was acting as a scaffold for tissue ingrowth with minor inflammatory cells. At six months, the material was seen to be covered with collagenous material, rather like fascia which interdigitated closely with the embedded polyester material. We had one patient who required arthroscopic release for stiffness after the index operation. The arthroscopic view showed regenerated tissue with good continuity and solid integration to the supraspinatus and greater tuberosity without defect, which was almost same as we found in the retrieved polyester study. The regenerated tissue over the augmentation device presented a firm consistency on palpation.

The ideal device for augmentation of rotator cuff repair should be designed with appropriate initial strength to meet the biomechanical demands, it must have adequate strength during the healing phase to stabilize the bone-tendon junction area, and it should cause no significant adverse effects that would require additional surgical intervention or removal. In our study, there was no failure case related to reactive synovitis or infection after operation.

The polyester device adds strength to the fixation of the cuff without hindering the recovery process. We believe the results of this study support the use of the polyester device in the repair of large or massive rotator cuff tears using the transosseous bone tunnel technique, although prospective randomized studies are needed to determine the extent to which this technique improves patient outcome. Another limitation of this study is that no studies on the comparative group of patients who were treated with conventional open method were performed. However, our study aimed to assess the feasibility of reconstruction of large or massive rotator cuff tears with this novel technique.

In conclusion, based on our clinical results, we consider the technique of using polyester augmentation device for the reconstruction of large or massive rotator cuff tears, a satisfying procedure in this complex and challenging group of patients.

The embroidered polyester augmentation device was successfully used both as an augmentation device and a scaffold for the reconstruction of large or massive rotator cuff tears. However, further large clinical studies are needed to elucidate the role of embroidered polyester as a therapeutic option of the challenging problem of large or massive rotator cuff tears.    References  

1. Ahmad CS, Stewart AM, Izquierdo R, Bigliani LU. Tendon-bone interface motion in transosseous suture and suture anchor rotator cuff repair techniques. Am J Sports Med. 2005;33:1667-71.

2. Amstutz HC, Sew Hoy AL, Clarke IC. UCLA: anatomic total shoulder arthroplasty. Clin Orthop. 1981;155:7-20.

3. Aoki M, Okamura K, Fukushima S, Takahashi T, Ogino T. Transfer of latissimus dorsi for irreparable rotator-cuff tears. J Bone Joint Surg Br. 1996;78:761-6.  

4. Audenaert E, Van Nuffel J, Schepens A, Verhelst M, Verdonk R. Reconstruction of massive rotator cuff lesions with a synthetic interposition graft: a prospective study of 41 patients. Knee Surg Sports Traumatol Arthrosc. 2006; 14: 360-4.

5. Burkhart SS. Arthroscopic debridement and decompression for selected rotator cuff tears: Clinical results, pathomechanics, and patient selection based on biomechanical parameters. Orthop Clin North Am. 1993; 24: 111-23.

6. Burkhart SS. Partial repair of massive rotator cuff tears: the evolution of a concept. Orthop Clin North Am. 1997;28:125-32.

7. Caldwell GL, Warner JP, Miller MD, Boardman D, Towers J, Debski R. Strength of fixation with transosseous sutures in rotator cuff repair. J Bone Joint Surg Am. 1997;79:1064-8.

8. Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 ; 67:974-9.

9. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop. 1987;214:160-4.

10. France EP, Paulos LE, Harner CD, et al. Biomechanical evaluation of rotator cuff fixation methods. Am J Sports Med. 1989;17:176-181.

11. Galatz LM, Ball CM, Teefey SA, Middleton WD, Yamaguchi K. The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am. 2004;86:219-24.

12. Gartsman GM. Massive, irreparable tears of the rotator cuff: Results of operative debridement and subacromial decompression. J Bone Joint Surg Am. 1997;79:715-21.  

13. Gazielly DF, Gleyze P, Montagnon C. Functional and anatomical results after rotator cuff repair. Clin Orthop. 1994; 304:43-53.  

14. Gerber C, Fuchs B, Hodler J. The results of repair of massive tears of the rotator cuff. J Bone Joint Surg Am. 2000;82:505-15.

15. Gerber C, Schneeberger AG, Beck M, Schlegel U.  Mechanical strength of repairs of the rotator cuff. J Bone Joint Surg Br. 1994;76:371-80.

16. Gerber C, Schneeberger AG, Perren SM, Nyffeler RW. Experimental rotator cuff repair. J Bone Joint Surg. 1999;81:1281-1290.

17. Guven O, Bezer M, Guven Z, Gokkus K, Tetik C. Surgical technique and functional results of irreparable cuff tears reconstructed with the long head of the biceps tendon. Bull Hosp Jt Dis. 2001;60:13-7.

18. Hirooka A, Yoneda M, Wakaitani S, Isaka Y, Hayashida K, Fukushima S, Okamura K. Augmentation with a Gore-Tex patch for repair of large rotator cuff tears that cannot be sutured. J Orthop Sci. 2002;7:451-6.

19. Kaar T, Schenck R, Wirth M, Rockwood C. Complications of metallic suture anchors in shoulder surgery: A report of eight cases. Arthroscopy. 2001; 17:31-37.

20. Kessler KJ, Bullens-Borrow AE, Zisholtz J. LactoSorb plates for rotator cuff repair. Arthroscopy. 2002;18:279-83.

21. Meyer DC, Fucentese SF, Koller B, Gerber C. Association of osteopenia of the humeral head with full-thickness rotator cuff tears. J Shoulder Elbow Surg. 2004;13:333-7.

22. Moore DR, Cain EL, Schwartz ML, Clancy WG Jr. Allograft reconstruction for massive, irreparable rotator cuff tears. Am J Sports Med. 2006; 34: 392-6.

23. Neviaser JS, Neviaser RJ, Neviaser TJ. The repair of chronic massive ruptures of the rotator cuff of the shoulder by use of a freeze-dried rotator cuff. J Bone Joint Surg Am. 1978; 60: 681-4.

24. Ozaki J, Fujimoto S, Masuhara K, Tamai S, Yoshimoto S. Reconstruction of chronic massive rotator cuff tears with synthetic materials. Clin Orthop. 1986;202:173-83.

25. Rockwood CA Jr, Williams GR Jr, Burkhead WZ Jr. Debridement of degenerative, irreparable lesions of the rotator cuff. J Bone Joint Surg Am. 1995;77:857-66.

26. Romeo AA, Hang DW, Bach BR Jr, Shott S.  Repair of full thickness rotator cuff tears. Gender, age, and other factors affecting outcome. Clin Orthop. 1999 ;367:243-55.  

27. Warner JJ, Parsons IM 4th. Latissimus dorsi tendon transfer: a comparative analysis of primary and salvage reconstruction of massive, irreparable rotator cuff tears. J Shoulder Elbow Surg. 2001 ;1:514-21.

 

 

 

 

Figure Legends

Figure 1. A. Identify the retracted distal stump and release adhesion. B. The rotator cuff is temporarily held with stay sutures along its free edge and mobilised and released as much as required both at the bursa and articular sides in order for the tendon to be brought into direct contact with the bone

 

Figure 2. At least, two rows of sutures with a minimum of ten stitches, which include three Mason-Allen sutures in each row, are placed along the free edge of the tendon grasping sufficient tissue to provide a good hold. The integral introducing leader is used to pass the free end of the device through the tunnel and out onto the lateral surface of the humerus.

 

Figure 3. The augmentation device is tensioned to bring the tendon into the bony trough and the appropriate fixation hole is selected in the main section of the device. The distal end of the device is secured in place with a single, fully threaded 4.5mm diameter cortical bone screw.