Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Rotator cuff tears are seen in 40% of subjects over age 50 57, with a prevalence known to
      increase with each decade of life 51. Each year rotator cuff disorders lead to 4.5 million
      physician visits, 40,000 inpatient surgeries, and 250,000 outpatient surgeries with costs of
      $17,427 per patient in 2004. As the population ages, the number of rotator cuff repair
      surgeries is increasing; in New York State, rotator cuff repairs increased by 50% over a 5
      years span 48. Unfortunately, surgically repaired rotator cuff tears fail in at least 20% and
      up to 94% of individuals 3, 9, 13, 20, 28, 40, 52, 58. While many non-modifiable variables
      have been associated with failure of repair, postoperative rehabilitation is a modifiable
      variable that has received little attention. The investigators propose a multicenter
      randomized controlled trial to study one important strategy for postoperative rehabilitation:
      early versus delayed onset of physical therapy. This pilot study will enroll patients with
      isolated supraspinatus tears who undergo a standard surgical repair technique. The
      investigators hypothesize that delaying the onset of physical therapy will improve healing
      and patient outcomes. Our primary outcome variable is the Western Ontario Rotator Cuff (WORC)
      Index (a disease specific validated outcome measure). Because outcome measures may not always
      correlate with healing of rotator cuff repairs 50, our secondary outcome measure will be
      healing based on MRI scans 12 months after surgery.
    

Detailed description: 
      Surgically repaired rotator cuff tears fail at surprisingly high rates, approaching 20-94% as
      determined by MRI 3, 9, 13, 20, 28, 40, 52, 58. Non-modifiable variables associated with
      rotator cuff repair failure include: duration of symptoms 9, 19, 39, fatty infiltration of
      the atrophied muscle 6, 15, 17, larger rotator cuff tears 6, 9, 19, 20, 21, 26, 39, 47, older
      age 9, 20, 22, 48, 55, co-morbidities 48, and workers compensation claims 2, 22, 23.
      Potentially modifiable variables include: tobacco use 11, 38, limited preoperative range of
      motion 45, and surgeon volume 48.

      Two other modifiable variables are surgical technique and postoperative management. As
      advances in arthroscopic techniques have evolved, a variety of studies have evaluated
      different surgical techniques in clinical series and trials 3, 4, 20, 12, 18, 31, 36. In
      2006, Park et al described the "transosseous equivalent" repair technique characterized by
      sutures secured medially, passed through and over the top of the rotator cuff, and then
      secured laterally 44. This method of repair has been shown to have better biomechanical
      properties and produce superior healing rates compared to other techniques in randomized
      clinical trials 5, 12. These data suggest this technique is currently the best available
      method to repair rotator cuff tears.

      Postoperative management of patients who have had rotator cuff repair has received little
      attention in the literature, yet is likely one of the most important modifiable variables
      that can influence rotator cuff repair integrity. It has been argued that early physical
      therapy may increase failure rates of rotator cuff repair 1, 14. This has led some to
      recommend delaying therapy for up to 6 weeks after surgery.

      Three groups have studied delaying the onset of physiotherapy in patients with full thickness
      rotator cuff tears. Klintberg et al 29 performed a randomized trial on patients who underwent
      open rotator cuff repair comparing two postoperative physical therapy protocols: a
      "Progressive Therapy Group" ¬ (started the day after surgery with passive range of motion and
      dynamic muscle activation of the rotator cuff, a sling was removed after 4 weeks and rotator
      cuff loading was progressive through the rehabilitation), and a "Traditional Group" (passive
      range of motion the day after surgery with immobilization in a sling for 6 weeks during which
      time no rotator cuff loading was applied). In this trial no significant differences in
      outcome were detected.

      In contrast to this, Deutsch et al 7 reported on 70 patients who had a single row
      arthroscopic rotator cuff repair with simple suture configuration randomized to one of two
      physical therapy protocols that were different only in that the "Standard" protocol began
      passive forward elevation on postoperative day 7 (N=37), whereas the "Delayed" protocol began
      passive forward elevation after 4 weeks (N=33). At 6 months range of motion was not
      different, however ultrasound examination demonstrated 19% of the repairs failed in the
      "Standard" group, whereas only 9% failed in the "Delayed" group (p<0.05).

      In a prospective cohort study presented by Accousti et al 1, 56 patients were all managed by
      6 weeks of immobilization following rotator cuff repair. When immobilization was removed, 13
      patients were considered "stiff" with limited motion, and 43 had "good" passive motion. By
      one year none of the patients were considered stiff. In the "stiff" group rotator cuff
      repairs failed in 30%, whereas in the group with "good" motion at six weeks 62% of repairs
      failed.

      These data, while limited, suggest that some period of immobilization may improve healing of
      rotator cuff repairs. The effect of immobilization on other measures of outcome is unclear.
      Unfortunately none of these studies used the transosseous equivalent repair technique.

      The purpose of this study is to compare two different strategies of postoperative management
      in patients with isolated supraspinatus rotator cuff tears repaired with a standardized
      "SpeedBridge" arthroscopic transosseous equivalent technique, using a disease specific
      validated measure of outcome (WORC index) as the primary outcome variable. The design will be
      a multicenter randomized trial comparing immediate to delayed physical therapy. As patient
      oriented outcomes frequently do not correlate with rotator cuff repair healing 50, the second
      aim is to study the effect of these rehabilitation paradigms on rotator cuff healing by MRI.
    

Intervention name(s): Immediate Postoperative Therapy; Delayed Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): All patients will undergo a 16 week postoperative therapy program (a formal physical therapy program, a home exercise program or a combination of both). Immediate and delayed therapy are the current standard of care for postoperative physical therapy. The Immediate group will began physical therapy 3-7 days postoperatively.; All patients will undergo a 16 week postoperative therapy program (a formal physical therapy program, a home exercise program or a combination of both). Immediate and delayed therapy are the current standard of care for postoperative physical therapy. The delayed group will began physical therapy 6 weeks postoperatively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Rotator Cuff Tear Repair; Rotator Cuff Tear Repair and postoperative treatment