Early Mobilization Following Mini-Open Rotator Cuff Repair
Condition: Full Thickness Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine if early active range of motion after
      mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6
      weeks and 3 months after surgery. The secondary objective of this study is to determine if
      early mobilization improves disease-specific quality of life and promotes earlier return to
      work/function.

      Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of
      range of motion, improved disease specific quality of life and earlier return to
      work/function if allowed to begin early active range of motion compared to subjects who are
      immobilized in a sling for 6 weeks.
    

Detailed description: 
      The rotator cuff is a group of four muscles around the shoulder. They function to provide
      both shoulder mobility and power as well as stability. Rotator cuff tears can be a
      significant cause of pain and disability for the patient. Surgical repair is done to
      reconnect the torn tendon(s) to the bone and has been shown to be an effective treatment in
      the presence of full-thickness tears. The goals of Rotator Cuff (RC)surgery are to decrease
      pain, increase range of motion(ROM) and strength. This is done with a small incision called a
      mini-open. Standard care following this surgical repair is to be placed in a sling for 6
      weeks to protect the repaired shoulder tendons. During this time ROM exercises are done using
      the non-operated arm for assistance. No active or voluntary movement is allowed during the
      first 6 weeks. Unfortunately, some of these patients develop shoulder stiffness which slows
      their recovery and return to work or daily activities and may result in increased use and
      cost of rehabilitation services.

      The purpose of this study is to determine if following a RC repair, patients can safely stop
      wearing their sling and begin active ROM for activities of daily living as early as pain and
      comfort allow. A total of 190 patients have been recruited to this study (95/group) were
      randomly assigned to one of two study groups. Patients in Group A (sling for 6 weeks) will
      wear their sling for 6 weeks. Self-assisted ROM exercises are allowed at any time, but active
      movement will not be allowed until 6 weeks after surgery. Patients in Group B (Sling as
      needed) will be allowed to remove their sling as early as pain and comfort allow.
      Self-assisted ROM exercises are allowed at any time as are active ROM for activities of daily
      living. Patients who agree to participate will be seen by their surgeon and the research
      coordinator for a baseline assessment before surgery and again at 2 & 6 weeks, 3, 6, 12 and
      24 months after surgery. Each visit will include a ROM assessment and disease specific
      quality of life questionnaires. Patients will also undergo an Ultrasound exam at a minimum of
      2 years after surgery to verify the integrity of their RC repair. Differences in ROM,
      questionnaire scores, RC integrity and adverse events will be examined between the two
      groups.
    

Intervention name(s): Sling; No sling
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.; Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: rotator cuff tear; arthroscopically assisted; health related quality of life(HRQL); functional outcome