Department of Orthopaedic Sports Medicine

Technical University of Munich, Germany

(Director: Univ.-Prof. Dr. A.B. Imhoff)

Connollystr. 32

80809 München

Germany

Telephone: 0049 / 89 / 2892—4462

Fax: 0049 / 89 / 2892—4484

The work was done without financial support.

Key words:

foreign-body-reaction; Suretac; arthroscopic shoulder stabilization; shoulder instability

From 1.4.96-31.12.97, 70 patients underwent arthroscopic shoulder stabilisation. Each patient received a prophylactic cephalosporin medication. Usually we use the posterior portal, the anterior-inferior portal, just above the subscapularis, the anterior-superior portal, and for SLAP-lesions the supraspinatus fossa portal. Postoperatively the patients arm is immobilized in a Gilchrist-dressing for 1 day. In the first six postoperative weeks external rotation is not allowed. During this period the patient performs isometric and pendular exercises.

In 4 patients (3 men, 1 women; average 27 years old) with 3 SLAP-lesions grade 2 and one posttraumatic anterior shoulder instability we observed following complications (see table patient characteristics): 2 patients (patient 1+2) complained of shoulder pain after an unintentional abduction-external rotation manoeuver of the operated shoulder in the first two postoperative weeks, one (patient 4: W.D) 5 weeks postoperatively. Patient 3 had pain and slight temperature at the 14th post-op. day and who was treated with antibiotics for 14 days. All patients complained of shoulder pain further on and did not regenerate under physical therapy. Clinically, all had a painfully reduced shoulder motion. The blood parameters revealed an increase in C-reactive protein (normal: < 0,5 mg/dl; our patients 0,7-9,1mg/dl) and erythrocyte sedimentation rate but no leukocytosis. There was only a mild swelling and hyperthermia of the shoulder. Conventional x-rays of the shoulder were normal, there were no signs of osteolysis or bony destruction. In MRI there was intraarticular fluid and a synovial enhancement after Gadolinium injection. A gadolinium uptake was also in the head of the humerus. Particles of the Suretac were visible in the adjacent tissue (Fig.1+2) All patients underwent re-arthroscopy (average 65 days (14-120days) for bacterial examination, irrigation, debridement and if necessary,refixation.

There was a massive synovitis in all patients with an intraarticular effusion, but bacteriological cultures were all negative. The Suretac devices were broken (Fig.3) and loose fragments of screw material fell out of the cavity (Fig. 4) Because of persistent defects and shoulder instability Fastak (Arthrex, Naples, Fl., USA) was used and Mitek (Mitek Division, Norderstedt, Germany) for stabilisation in each patient (patient 2 +4). All patients underwent an arthroscopic synovectomy.

The histologic examination of the hypertrophic synovia revealed fibrous tissue with a large infiltration of phagocytic cells (histiocytes, multinucleated giant cells) and birefringent polymeric particles, which were surrounded by or within histiocytes and multinucleated giant cells (Fig. 5-8). Only the histology of patient S.H. showed a beginning of cell infiltration with slight fibrosis but no birefringent particles in the synovia.

Postoperatively all patients were painfree and progressed to active-assisted and active range of motion.

Despite the use of an absorbable implant eliminating concerns about articular injury from metal implants, adverse reactions to it can aggravate resultant recovery. Edwards et al. report about 5 patients of 100 with an adverse reaction to the Suretac device. Interestingly 3 out of 5 patients had a SLAP II lesion for original indication.4 Segmüller diagnosed in 3 patients (4,2%) an adverse reaction to the polygluconate implant at a second arthroscopy.14 Her indication for a second arthroscopy was pain and restricted range of motion 2 to 6 months after the original surgery, suggesting a possible infection or the beginning of an adhesive capsulitis. She noted no long-term side effects after the adverse reaction. Warner 22 reported no adverse reactions using the Suretac device in 7 patients with SLAP-lesion. In our series 3 out of 20 (15%) patients with SLAP-lesion had an adverse reaction. Segmüller et al. reported about the results of 17 SLAP repairs with 83% excellent or good, 94% improved and 53% returning to preinjury sporting activities.14 Resch et al.12 had 57% excellent results for 14 patients with SLAP-lesions, stabilized with SURETAC. Using transglenoid sutures Yoneda reported about 80% good or excellent results in 10 patients.24 It is unclear whether the placement of a further device in the posterosuperior aspect of the detached biceps origin would improve the outcome significantly. Probably there is much more tension-force, acting like shear, on the Suretac device in a SLAP-lesion than in anterior instability. Future biomechanical investigations are necessary to answer this question. If one regards the initial failure strength of the Suretac compared to other repair techniques like single-suture and two-suture, there was no break down or pull out, but suture breakage and soft-tissue failure despite the lowest values for the Suretac device.11 Shall evaluated 3 mechanical soft tissue fixation devices (SuperAnchor, Suretac, and the Instrument Makar Bioabsorbable Staple) by examining ultimate tensile failure in Bankart repair and reported the most common failure was suture breakage for the Mitek (71%), anchor pullout from bone for the IM Staple (75%) and the Suretac (94%).15 Interestingly he noted, that a number of the staples broke under load. Insufficient capture and compression of capsular tissue by the Suretac device could be a possible cause of failure. Shea et al. compared the ultimate failure strengths of traditional suture techniques and staple repairs in a canine model and found that ultimate failure of both the suture and staple techniques were signifacantly lower than those for intact labrum-bone complexes.15 They advise caution when instituting motion after arthroscopic Bankart procedures.

The bioabsorbable fixation devices, used in orthopedic surgery, differ in design and in type of polymer material, which ultimately determines the biocompatibility and in vivo degradation behaviour. Most of the authors did not see any clinical signs of foreign-body reaction to bioabsorbable interference screws.19 Other authors describe a non-specific foreign-body reaction especially to polglycolide, with osteolytic increase of the diameter of the implant channel.1,2,7 Furthermore the cytological analysis of fluid aspirated from the effusion around a polyglycolic acid osteosynthesis implant showed predominance of inflammatory monocytes and lymphocytes.13

Conclusions:The most common failure was breakage of Suretac device, propably caused by incautious shoulder movement in the first postoperative weeks. Thereby particles of the Suretac are released into the shoulder joint and cause a mechanical irritation or reactive synovitis, accompanied by release of prostaglandins with clinically observed pain and reduced shoulder motion. It seems, that especially SLAP-lesions are unfit for stabilisation with Suretac device. In our patients it was rather a mechanical pitfall than a predisposition to exaggerated inflammatory response.

2.Böstman O M: Intense Granulomatous Inflammatory Lesions Associated With Absorbable Internal Fixation Devices Made of Polyglycolide in Ankle Fractures. Clin. Orthop. 278, 193-199, 1992

3.DuToit G., Roux D: Recurrent dislocation of the shoulder: A 24 year study of the Johannesburg stapling operation. J.Bone Joint Surg. 38: 1-12, 1956

4.Edwards DJ., Hoy G, Saies AD, Hayes MG.: Adverse reactions to an absorbable Shoulder fixation device. J.Shoulder Elbow Surg. 3 , 230-233, 1994

5.Fellmann J, Imhoff AB, DeSimoni C.: Schulterinstabilität: Erfahrungen mit arthroskopischen Rekonstruktionseingriffen. Sportorthopädie/ Traumatologie 11 (4), 255-262, 1995

6.Hawkins RB: Arthroscopic stapling repair for shoulder instability: a retrospective study of 50 cases. Arthroscopy 5, 122-128, 1989

7.Hovis D, Buchholz R: Polyglycolide Bioabsorbable Screws in the Treatment of Ankle Fractures. Foot & Ankle International 18, 128-131, 1997

8.Imhoff AB, DeSimoni C.: Die arthroskopische Schulterstabilisierung mit Suretac-Eine Komplikationsanalyse. Davos, 2nd Central European Congress of Traumatology, May 29-June 1, 1996, Switzerland

9.Johnson L.: Diagnostic an surgical arthroscopy of shoulder. St.Louis, MO, CV Mosby, pp 276-352, 1993

10.Lane J., Sachs R., Riehl B.: Arthroscopic staple capsulorraphy: A long-term follow-up. Arthroscopy 9: 190-194, 1993

11.McEleny ET, Donovan MJ, Shea KP, Novak MD.: Initial failure strength of open and arthroscopic Bankart repairs. Arthroscopy 11, 426-431, 1995

12.Resch H., Golser K, Thoeni H, Sperner G: Arthroscopic repair of superior labral detachment (the SLAP lesion). J. Shoulder Elbow Surg. 2, 147-155, 1993

13.Santavirta S, Konttinen Y, Saito T, Grönblad M, Partio E, Kemppinen P, Rokkanen P: Immune Response to Polyglycolic Acid Implants. J.Bone Joint Surg 72-B, 597, 1990

14.Segmüller H, Hayes M, Saies A: Arthroscopic repair of glenolabral injuries with an absorbable fixation device. J. Shoulder Elbow Surg. Vol. 6, No4, 383-392, 1997

15.Shall LM, Cawley P: Soft Tissue Reconstruction in the Shoulder: Comparison of Suture Anchors, Absorbable Staples, and Absorbable Tacks. AmJ. Sports Med 22, 715-718, 1994

16.Shea KP, O`Keefe Jr RM, Fulkerson, JP: Comparison of initial pull-out strength of arthroscopic suture and staple Bankar repair techniques. Arthroscopy 8, 179-182, 1992

17.Shea K., Lovallo J.: Scapulothoracic penetration of a beath pin: An unusual complication of arthroscopic Bankart repair. Arthroscopy 7: 115-117, 1991

18.Snyder S: Arthroscopic technique for the anterior shoulder stabilization using the Suture Shuttle Relay and implantable bone anchors. Presented at the 13th Annual Meeting of the Arthroscopy Association of North America. Orlando, Fl, April 1994

19.Stähelin AC, Weiler A, Rüfenacht HJ, Hoffmann R, Geissmann A, Feinstein R.: Clinical Degradation and Biocompatibility of Different Bioabsorbable Interference Screws: A Report of Six Cases. Arthroscopy 13, 238-244, 1997

20.Warner J, WarrenRF: Arthroscopic Bankart repair using a cannulated absorbable fixation device. Oper Tech Orthop 1, 192-198, 1991

21.Warner J, Miller M, Marks P.: Arthroscopic Bankart repair with the Suretac device: Clinical and experimental observations. Arthroscopy 11: 2-20, 1995

22.Warner JP, Kann S, Marks P.: Arthroscopic Repair of Combined Bankart and Superior Labral Detachment Anterior and Posterior Lesions: Technique and Preliminary Results. Arthroscopy 10(4), 383-391, 1994

23.Wolf E., Wilk R., Richmond J: Arthroscopic Bankart repair using suture anchors. Op Tech Orthop 1: 184-191, 1991

24.Yoneda M, Hirooka A, Saito S: Arthroscopic stapling for detached superior glenoid labrum. J.Bone Joint Surg. 73 B, 746-750, 1991

25.Zuckerman JD, Matsen FA: Complications about the glenohumeral joint related to the use of screws and staples. J. Bone Joint Surg. 66A, 175-180, 1984

Table 1: Patient characteristics

Fig. 3. (Patient S.H.) broken and loose Suretac at the screw-head/neck junction, synovitis. Arthroscopic picture

Fig. 4. (Patient W.D.) loosed Suretac. Arthroscopic picture.

Fig. 5. Foreign body granulation tissue with infiltration of histiocytes and multinucleated giant cells with particles inside.

(Stain, hematoxylin and eosin; original magnification, X 64

Fig. 6. Foreign body granulation tissue with infiltration of histiocytes and multinucleated giant cells with birefringent particles inside.

(Stain, hematoxylin and eosin; original magnification, X 64, under polarized light)

Fig.7. Fibrous tissue with infiltration of phagocytic cells and particles, surrounded by histiocytes. (Stain, hematoxylin and eosin; original magnification, X 128)

Fig. 8. Fibrous tissue with infiltration of phagocytic cells and particles, surrounded by histiocytes (Stain, hematoxylin and eosin; original magnification, X 128, under polarized light)

Dr. A. Burkart

Department of Orthopaedic Sports Medicine

Technical University of Munich

Connollystr. 32

80809 München

Germany

The initial failure strength of the Suretac compared to other repair techniques like single-suture and two-suture using a canine model of Bankart repair showed no break down or pull out, but suture breakage and soft-tissue failure despite the lowest values for the Suretac device. (McEleney)

Though the initial experience with the Suretac device of only an 8% failure rate was encouraging (Warner/Warren), longer follow-up has demonstrated a recurrence rate of 20%.