e44(1) C OPYRIGHT Ó 2014

BY

T HE J OURNAL

OF

B ONE

AND J OINT

S URGERY, I NCORPORATED

Effect of Immobilization without Passive Exercise After Rotator Cuff Repair Randomized Clinical Trial Comparing Four and Eight Weeks of Immobilization Kyoung Hwan Koh, MD, Tae Kang Lim, MD, Min Soo Shon, MD, Young Eun Park, MD, Seung Won Lee, MD, and Jae Chul Yoo, MD Investigation performed at the Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

Background: While animal studies have shown better healing with a longer duration of protection without motion exercise after rotator cuff repair, supporting clinical studies are rare. The purpose of this study was to assess the effect of immobilization following rotator cuff repair and to determine whether there was any difference in clinical outcome related to the duration of immobilization. Methods: One hundred patients who underwent arthroscopic single-row repair of a posterosuperior rotator cuff tear (mean, 2.3 cm in the coronal-oblique plane and 2.0 cm in the sagittal-oblique plane) were prospectively randomized to be treated with immobilization for four or eight weeks. During the immobilization period, no passive or active range-of-motion exercise, including pendulum exercise, was allowed. According to the intention-to-treat protocol and full analysis set, eighty-eight patients were evaluated clinically and with magnetic resonance imaging postoperatively, after exclusion of twelve patients without postoperative clinical evaluation. Ranges of motion, clinical scores, and retear rates were compared between the four and eight-week groups. Ninety-eight patients were contacted by telephone at a mean of thirty-five months to investigate the clinical outcomes. Results: The mean duration of immobilization was 4.1 weeks in the four-week group and 7.3 weeks in the eight-week group. There were nine full-thickness retears (10%), and 89% of the patients rated their result as excellent or good. There were five full-thickness retears in the four-week group and four in the eight-week group (p = 0.726). At the time of final follow-up, the two groups showed no differences in range of motion or clinical scores. However, the proportion showing stiffness was higher in the eight-week group (38% compared with 18%, p = 0.038). Conclusions: Eight weeks of immobilization did not yield a higher rate of healing of medium-sized rotator cuff tears compared with four weeks of immobilization. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.

D

espite improved results of rotator cuff repair, retear rates remain a major concern1,2. In an effort to improve the healing rate and decrease the retear rate, numerous investigators have explored better suture techniques. However, less attention has been given to the rehabilitation protocol, which can affect the surgical results. The primary goal of rehabilitation is to protect the repair and simultaneously achieve a range of motion of the shoulder. In most studies concerning rotator cuff repair, the rehabilitation protocol

incorporated immediate passive range-of-motion exercise for the first three to six weeks with the patient wearing an abduction shoulder brace during that time3-9. However, this protocol was primarily based on clinical experience10, and on patients treated with open surgery, not arthroscopic surgery. There are few clinical studies regarding the impact of postoperative rehabilitation on healing or stiffness, especially after arthroscopic rotator cuff repair. Animal studies of the effects of postoperative immobilization or early range-of-motion exercise have demonstrated

Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

J Bone Joint Surg Am. 2014;96:e44(1-9)

d

http://dx.doi.org/10.2106/JBJS.L.01741

e44(2) TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RG V O L U M E 96-A N U M B E R 6 M A R C H 19, 2 014 d

d

d

E F F E C T O F I M M O B I L I Z AT I O N R O TAT O R C U F F R E PA I R

WITHOUT

PA S S I V E E X E R C I S E A F T E R

Fig. 1

CONSORT flow diagram. ROM = range of motion and PVAS = pain visual analog scale.

better healing and improved mechanical properties when immobilization without passive motion exercise was used after rotator cuff repair11-19. Some studies showed less stiffness with longer immobilization and no passive motion after rotator cuff repair in a rat model15,16. The purpose of the present study was to evaluate the effects of immobilization without any passive motion exercise on healing and the development of stiffness after arthroscopic rotator cuff repair and to determine if there was any difference in clinical outcome related to the duration of immobilization. Our null hypothesis was that there were no differences in retear rates, clinical scores, and shoulder stiffness with immobilization longer than four weeks.

Patient Enrollment and Randomization

his randomized clinical trial was approved by our institutional review board (IRB number 2008-04-051-001) and registered with ClinicalTrials.gov (NCT 00891566) prior to patient enrollment.

From April 2008 to May 2009, we prospectively recruited participants who met the inclusion criteria, which were painful dysfunction of the shoulder despite conservative treatment for at least three months, no evident history of trauma, and a full-thickness posterosuperior tear 2 to 4 cm in size (measured intraoperatively with a probe with 5-mm-spaced markings). The exclusion criteria were a history of shoulder surgery, fracture, instability, or infection; an incomplete repair; an open repair; and rheumatoid or degenerative arthritis. Patients with limited shoulder motion were not excluded because studies have shown that preoperative stiffness managed concomitantly during rotator cuff 20,21 repair does not alter the clinical outcome . We did not exclude partialthickness/partial length subscapularis tears found during arthroscopic evalua22 tion . All eligible patients provided informed consent before surgery, and final enrollment was determined at the completion of surgery. Each patient was randomly assigned to be treated with either four or eight weeks of immobilization on the basis of a random sequence determined by a computerized randomnumber generator (Excel; Microsoft, Redmond, Washington). A sealed envelope containing the randomly assigned duration of immobilization was opened by the circulating nurse. Figure 1 provides our CONSORT (Consolidated Standards of Reporting Trials) statement.

Sample Size Calculation

Surgical Technique

The primary outcome variable for the sample size calculation was the retear rate. A power analysis performed prior to the study indicated that a sample size of forty-two patients in each cohort would provide 90% power (beta = 0.1, alpha = 0.05) to detect a difference of 30% (10% versus 40%) in the retear rate between groups. Fifty patients in each group were enrolled to account for a possible loss to follow-up of 15% to 20%. Simple randomization was conducted.

The surgery and postoperative care programs, other than the duration of immobilization, were identical for all study participants. All rotator cuff repairs were performed with the patient in a lateral decubitus position. With the patient under anesthesia, we performed manipulation to address any limitation of motion before the creation of arthroscopic portals. After creation of routine posterior and anterior portals, any intra-articular pathology was addressed

Materials and Methods

T

e44(3) TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RG V O L U M E 96-A N U M B E R 6 M A R C H 19, 2 014 d

d

d

E F F E C T O F I M M O B I L I Z AT I O N R O TAT O R C U F F R E PA I R

WITHOUT

PA S S I V E E X E R C I S E A F T E R

TABLE I Comparisons of Ranges of Motion, Clinical Scores, and MRI Measurements Preoperatively and Postoperatively Between Four and Eight-Week Groups: Analysis of Entire Series Entire Series (N = 88) Preoperative Range of motion* Flex.-ext. (deg) Int. rotat.† Ext. rotat. (deg) Clinical scores* Pain VAS Constant ASES Tear size on MRI* (mm) Coronal-oblique plane Sagittal-oblique plane Goutallier fatty degeneration* (stage) Supraspinatus Infraspinatus Subscapularis Global fatty degeneration index* Supraspinatus atrophy (no. [%]) Yes No 6 months Range of motion* Flex.-ext. (deg) Int. rotat.† Ext. rotat. (deg) Stiffness‡ (no. [%]) Clinical scores* Pain VAS Constant ASES 24 months Range of motion* Flex.-ext. (deg) Int. rotat.† Ext. rotat. (deg) Stiffness‡ (no. [%]) Clinical scores* Pain VAS Constant ASES Postoperative MRI Sugaya classification§ (no. [%]) I II III IV V Full-thickness retear# (no. [%])

4-Wk Group (N = 40)

8-Wk Group (N = 48)

P Value

143.8 (28.7) 10.1 (4.3) 40.8 (19.0)

137.7 (31.8) 10.1 (4.6) 39.0 (18.3)

148.8 (25.0) 10.1 (4.1) 42.3 (19.6)

0.065 0.941 0.456

5.7 (2.1) 52.7 (18.0) 45.2 (18.3)

5.8 (2.1) 50.9 (17.0) 44.4 (18.9)

5.6 (2.1) 54.2 (18.8) 45.8 (17.9)

0.717 0.433 0.743

22.7 (9.0) 19.6 (8.2)

23.7 (8.4) 19.4 (7.6)

21.9 (9.6) 19.7 (8.7)

0.198 0.802

1.8 (0.8) 1.0 (0.7) 0.6 (0.8) 1.1 (0.6)

1.9 (0.9) 0.9 (0.7) 0.6 (0.8) 1.2 (0.6)

1.7 (0.8) 1.0 (0.7) 0.6 (0.8) 1.1 (0.5)

0.238 0.711 1.000 0.674 0.306

26 (29.5%) 62 (70.5%)

14 (35.0%) 26 (65.0%)

12 (25.0%) 36 (75.0%)

128.3 (24.9) 11.1 (3.9) 18.8 (15.8) 45 (51.1%)

126.9 (28.3) 10.6 (4.2) 18.6 (16.5) 21 (52.5%)

129.5 (22.1) 11.5 (3.6) 18.9 (15.4) 24 (50.0%

0.922 0.166 0.992 0.815

2.7 (1.7) 64.3 (17.1) 68.0 (17.4)

2.7 (1.5) 65.1 (17.5) 68.0 (17.4)

2.7 (1.8) 63.7 (16.9) 68.0 (17.6)

0.624 0.714 0.985

142.6 (24.3) 9.3 (2.9) 31.2 (20.1) 25 (28.4%)

143.7 (23.5) 9.1 (2.9) 33.1 (18.8) 7 (17.5%)

141.7 (25.2) 9.4 (2.9) 29.5 (21.2) 18 (37.5%)

0.698 0.688 0.326 0.038

1.0 (1.4) 87.3 (12.7) 90.7 (13.3)

1.3 (1.8) 85.6 (15.6) 88.9 (16.2)

0.8 (1.0) 88.7 (9.7) 92.1 (10.2)

0.203 0.572 0.559 0.921

36 (40.9%) 29 (33.0%) 14 (15.9%) 3 (3.4%) 6 (6.8%) 9 (10.2%)

15 (37.5%) 13 (32.5%) 7 (17.5%) 2 (5.0%) 3 (7.5%) 5 (12.5%)

21 (43.8%) 16 (33.3%) 7 (14.6%) 1 (2.1%) 3 (6.3%) 4 (8.3%)

0.726

continued

e44(4) TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RG V O L U M E 96-A N U M B E R 6 M A R C H 19, 2 014 d

d

d

E F F E C T O F I M M O B I L I Z AT I O N R O TAT O R C U F F R E PA I R

WITHOUT

PA S S I V E E X E R C I S E A F T E R

TABLE I (continued) Entire Series (N = 88)

4-Wk Group (N = 40)

8-Wk Group (N = 48)

P Value

1.5 (0.7) 1.0 (0.6) 0.6 (0.7) 1.0 (0.5)

1.7(0.8) 1.0 (0.6) 0.6 (0.6) 1.1 (0.5)

1.4 (0.6) 1.0 (0.6) 0.6 (0.7) 1.0 (0.5)

0.164 0.949 0.976 0.532

5 (12.5%) 35 (87.5%)

3 (6.3%) 45 (93.8%)

Goutallier fatty degeneration* (stage) Supraspinatus Infraspinatus Subscapularis Global fatty degeneration index* Supraspinatus atrophy (no.) Yes No

0.460

*The values are given as the mean, with the standard deviation in parentheses. †Internal rotation was measured according to the place on the back that could be reached by the thumb, which was then converted to contiguous numbers (1 to 12 = T1 to T12 vertebrae, 13 to 17 = L1 to L5 vertebrae, 18 = sacrum, and 19 = greater tuberosity of the femur). ‡Patients who showed any one of the following three criteria were defined as having stiffness: forward elevation of

Effect of immobilization without passive exercise after rotator cuff repair: randomized clinical trial comparing four and eight weeks of immobilization.

While animal studies have shown better healing with a longer duration of protection without motion exercise after rotator cuff repair, supporting clin...
764KB Sizes 0 Downloads 3 Views