Post-op Rehabilitation's Influence on Tendon Healing & Clinical Outcomes Following Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to better understand the influence of post-operative
      rehabilitation on the rate of tendon healing and clinical outcomes following arthroscopic
      repair of the rotator cuff. There are two schools of thought on what type of therapy program
      is most beneficial following surgical cuff repair. However there has been little data
      available to compare them. Therefore, the investigators would like to compare these two
      standard plans of care so that the investigators may better define the safety and efficacy of
      early mobilization of the shoulder versus keeping the shoulder immobilized following surgical
      management.
    

Detailed description: 
      Background

      Rotator cuff disease is the leading cause of shoulder pain and disability. Previous studies
      regarding the epidemiology of rotator cuff disease have demonstrated a high incidence of age-
      related cuff tears, approximately 50% of individuals over the age of 55 years 1-3. Failure of
      conservative treatment often leads to surgical repair of the torn rotator cuff tendons.
      Indeed, rotator cuff repair is one of the most common surgical procedures currently performed
      in the shoulder with approximately 200,000 Americans undergoing this surgery yearly. We
      estimate that the Shoulder and Elbow Service at Washington University performs approximately
      400 rotator cuff repairs per year.

      One of the primary concerns following repair of the rotator cuff is healing of the repaired
      tendon. Although pain relief and improved shoulder function are predictable following rotator
      cuff repair, the rate of healing of the tendon repair has been much less consistent. In most
      instances, the repaired tissue is degenerative, 4, 5 possesses a poor blood supply 6 and,
      therefore, a limited ability to heal following repair. The rates of healing of the repaired
      cuff tendons have ranged from 6% to 80% across multiple studies depending on a variety of
      patient, tendon tear and surgery related factors 7-13. The major factors that have been
      identified to effect healing after rotator cuff repair include patient age, the size of the
      tear and the strength of the repair construct 8, 9, 12. To this point, there has been little
      data regarding the potential influence of postoperative rehabilitation of the shoulder on the
      structural integrity of rotator cuff repairs.

      The Shoulder and Elbow Service at Washington University has had extensive experience in
      studying various factors related to not only the progression of rotator cuff disease, but
      also tendon healing and outcomes of treatment 8, 14-16. A strength of our research team has
      been the collaborative experience developed with musculoskeletal radiologists at the
      Mallinkrodt Institute using high-resolution ultrasound to examine the integrity of the
      rotator cuff. Extensive data with ultrasound at this institution has validated it as a highly
      accurate means of identifying and quantifying rotator cuff tears in both the preoperative and
      postoperative settings 17-20. High-resolution ultrasound, in the hands of experienced
      musculoskeletal radiologists, has been proven to be more accurate than magnetic resonance
      imaging in assessing the integrity of the rotator cuff in the postoperative setting 19. With
      this modality, we have been able to study the outcomes and tendon healing rates following
      repair of the rotator cuff using conventional arthroscopic repair techniques 8. Recent data,
      from this institution, has also been completed examining the clinical outcomes and repair
      integrity following newer arthroscopic techniques (double-row rotator cuff repairs) in three
      separate patient populations: partial thickness cuff tears, full thickness cuff tears and
      revision of recurrent rotator cuff tears (manuscripts in progress). Our service has also been
      currently involved in a NIH R01 funded study prospectively examining factors related to the
      progression of asymptomatic rotator cuff tears over time. Given our research experience with
      ultrasound, the Shoulder and Elbow Service at Washington University has been uniquely
      positioned to study one of the most important issues in shoulder surgery - the effect of
      rehabilitation on healing of the rotator cuff following surgical repair.

      In addition to tendon healing, one of the primary goals following shoulder surgery is the
      early restoration of range of motion of the joint. Stiffness is one of the more common
      complications following shoulder surgery. Early range of motion helps to prevent the
      formation of adhesions within the joint and surrounding capsule and ligaments. Although most
      cuff repair constructs provide sufficient stability for early range of motion, the effect of
      motion at the repair site and the subsequent effect on healing are unknown in humans.
      Concerns regarding a deleterious effect of early motion on tendon healing have led some
      investigators to advocate substantially more conservative rehab after surgery. A delay in
      motion at the shoulder may theoretically improve the rate of tendon healing as stresses are
      minimized across the tendon repair site. This may be particularly important given that tendon
      repair constructs gradually becomes weaker before a more mature healing response occurs.
      However, a delay in motion will slow the return of mobility to the shoulder and may increase
      the risk of prolonged stiffness. Therefore, the clinician must balance the potential benefit
      (prevention of stiffness) against the potential harm (compromise of the surgical repair) of
      early rehabilitation following rotator cuff repair surgery. Despite the critical role early
      motion may have, there have been no published studies examining the influence of
      postoperative rehabilitation on the clinical outcomes and repair integrity following rotator
      cuff repair.

      The primary purpose of this study is to examine the influence of postoperative rehabilitation
      on the rate of tendon healing and clinical outcomes following arthroscopic repair of the
      rotator cuff. The ideal rehabilitation protocols following rotator cuff repair have yet to be
      determined. The clinical impact of this study will be significant in that we will better
      define the safety and efficacy of early mobilization of the shoulder following the surgical
      management of rotator cuff tears. A better understanding of appropriate postoperative
      physical therapy regimens is fundamental to the effective care of patients following rotator
      cuff repair. This study will serve as a basis for further research defining nonsurgical
      factors that influence tendon healing and outcome after rotator cuff repair.

      Specific Aim 1: To prospectively compare the rate of tendon healing following arthroscopic
      repair of small and medium sized tears of the rotator cuff in patients treated with two
      distinct postoperative rehabilitation protocols: immobilization versus early range of motion.

      Hypothesis 1: The rate of tendon healing following repair of small to medium sized rotator
      cuff tears will be the same for those patients treated with immobilization compared to an
      early range of motion protocol.

      Specific Aim 2: To prospectively compare the clinical outcomes following arthroscopic repair
      of small and medium sized tears of the rotator cuff in patients treated with two distinct
      postoperative rehabilitation protocols: immobilization versus early range of motion.

      Hypothesis 2: The clinical results following repair of small to medium sized rotator cuff
      tears will be substantially better for those patients treated with an early range of motion
      protocol as compared to those that were immobilized.

      A preliminary power analysis has been performed to determine the necessary number of patients
      for each group (alpha level =.05 and beta level = .20). Data from this institution suggests
      an 80% healing rate within this age group for small and medium size rotator cuff tears fixed
      with double-row cuff repair techniques. Given a presumed healing rate of 80% in the
      immobilization group, the numbers necessary to detect a difference in healing of 20% between
      the two rehabilitation protocols is 70 subjects in each group. Assuming a conservative
      attrition rate of 20%, we will estimate that a total of 170 subjects will need to be enrolled
      in this study.

      All rotator cuff repairs will be performed with a standard technique utilizing arthroscopic
      double-row suture anchor constructs. The surgery will also include subacromial decompression
      and acromioplasty as dictated by acromial degenerative changes. Concomitant procedures
      related to the biceps tendon will be performed as indicated. At the time of preoperative
      surgical evaluation, patients will be randomized by sealed envelope into one of two
      postoperative rehabilitation groups:

      Immobilization group: 6 weeks of sling shoulder immobilization. Immediate range of motion of
      the elbow, forearm, wrist and hand. At 6 weeks, PROM and stretching of the shoulder allowed
      under therapist direction. At 12 weeks, AAROM and AROM exercises will be initiated and
      capsular stretching advanced until full ROM achieved. Strengthening activities of the rotator
      cuff, deltoid and scapular stabilizers will be permitted at 4 months post surgery.

      Early range of motion group: Shoulder pendulum exercises will be allowed from the time of
      surgery. Immediate range of motion of the elbow, forearm, wrist and hand. At the first
      postoperative visit, PROM of the shoulder will be permitted under therapist direction.
      Patients will avoid IR and behind the back stretching. At 6 weeks, AAROM and AROM will be
      advanced as tolerated. Capsular stretching will be advanced until full range of motion is
      achieved. Strengthening activities of the rotator cuff, deltoid and scapular stabilizers will
      be permitted at 3 months post surgery.
    

Intervention name(s): Early Motion Protocol; Immobilization
Intervention type(s): Other; Other
Intervention description(s): Early range of motion group: Shoulder pendulum exercises will be allowed from the time of surgery. Immediate range of motion of the elbow, forearm, wrist and hand. At the first postoperative visit, PROM of the shoulder will be permitted under therapist direction. Patients will avoid IR and behind the back stretching. At 6 weeks, AAROM and AROM will be advanced as tolerated. Capsular stretching will be advanced until full range of motion is achieved. Strengthening activities of the rotator cuff, deltoid and scapular stabilizers will be permitted at 3 months post surgery.; Immobilization group: 6 weeks of sling shoulder immobilization. Immediate range of motion of the elbow, forearm, wrist and hand. At 6 weeks, PROM and stretching of the shoulder allowed under therapist direction. At 12 weeks, AAROM and AROM exercises will be initiated and capsular stretching advanced until full ROM achieved. Strengthening activities of the rotator cuff, deltoid and scapular stabilizers will be permitted at 4 months post surgery.
Other intervention name(s): physical therapy; early mobilization; Sling; Delayed active range of motion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: rotator cuff; post-operative immobilization protocol; post-operative early motion protocol; physical therapy; cuff repair integrity; ultrasound