Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability

Browse trials for

• Shoulder Dislocation 105

Keywords

• Bankart repair
• Remplissage
• Latarjet Coracoid Transfer
• Return to sport

Shoulder Dislocation

105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.

This study's planned enrollment of 72 is below the median of 86 across 28 observational studies indexed under Shoulder Dislocation.

Lead sponsor

Panam Clinic is the lead sponsor of 16 studies on the registry; 6 are open to participants now.

Study population

Groups and cohorts

• Bankart Repair and Remplissage

  Patients will undergo a standard arthroscopic anterior labral repair with a minimum of 3 suture anchors, followed by remplissage with 1 or 2 anchors, at the discretion of the treating surgeon.

  Procedure: Bankart Repair and Remplissage

• Latarjet Coracoid Transfer

  Patients will undergo a Latarjet coracoid transfer through a deltopectoral approach and horizontal split in the subscapularis at the superior 2/3, inferior 1/3 junction. The coracoid process will be oriented in the conventional manner, with the inferior surface against the glenoid vault, secured with two cannulated screws

  Procedure: Latarjet Coracoid Transfer

Interventions

• ProcedureBankart Repair and Remplissage

  Arthroscopic Bankart repair with a minimum of 3 anchors 1 or 2 anchor Remplissage subsequently performed with percutaneous anchor insertion in the base of the Hill-Sachs defect, and sutures passed in a horizontal mattress configuration 1 cm apart, tied in the subacromial space.

• ProcedureLatarjet Coracoid Transfer

  Coracoid transfer performed via deltopectoral approach with horizontal subscapularis split. Graft placed in the conventional orientation, secured with 2 screws, ensuring the graft is not lateral to the glenoid rim.

Primary outcomes

1. Western Ontario Shoulder Instability Index (WOSI)

   Is a disease specific, quality of life patient reported outcome measures (PROMS) for patients with shoulder instability. Patients use visual analog scales (VAS) to rate physical symptoms and impacts of the condition/treatment on sports/recreation/work, lifestyle, and emotions.

   Time frame: 24 months

2. Shoulder dislocation and recurrence

   Dislocation requiring reduction by a physician (ED) or surgery. Dislocations will be identified in two ways: 1) if the patient seeks treatment from the surgeon, the surgeon will notify the research coordinator who will document it accordingly, or 2) at each research postoperative examination, the research staff will ask patients if they experienced a dislocation or subluxation. These will be considered alongside the definition of recurrence from Kasik et al. that also includes subluxation, or positive findings during physical examination for shoulder instability (apprehension).

   Time frame: 24 months

3. Surgical complications, re-operations and revision surgeries

   Surgical complications will be documented at the time of surgery and at each postoperative interval. A surgical complication is defined as any undesirable, unintended and direct result of an operation affecting the patient that would not have occurred had the operation gone well as could reasonably be hoped (Sokol and Wilson, 2008) (i.e., infection, dislocation, neurological injury, and fracture (including periprosthetic and acromial fracture). Revision surgery and re-operations will be documented, including the reason for failure, date of revision/reoperation, and the procedure performed. Revision is defined as a change of an original component (partial or complete replacement). Re-operation is defined as any surgical procedure other than a revision.

   Time frame: 24 months

Secondary outcomes

1. Isokinetic Internal and External Rotation

   Internal and external rotation strength will be determined with an isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, USA). With the arm in 90 degrees shoulder abduction and elbow flexion and positioned in the scapular plane, patients will complete coupled concentric and eccentric shoulder internal and external rotation within a 90 degrees range of motion (-40 degrees internal rotation to 50 degrees external rotations). Three maximal effort (instructed to contract as hard and as fast as they can) repetitions will be completed at velocities of 60 and 180 degrees per second, with one-minute rest between testing speeds. Average peak torque of the three repetitions will be recorded for both IR and ER.

   Time frame: 24 months

2. Athletic Shoulder (ASH) Test

   The patient Is positioned prone with a foam block in place to support their forehand. The test is completed in three positions termed "I", with the arm positioned in 180 degrees of shoulder flexion, "Y, with the arm positioned in 135 degrees of shoulder abduction, and "T", with the arm positioned in 90 degrees of abduction. In each position, the palm of the hand rests on a force plate (AMTI, MA, USA). The patient will complete a warm-up of two submaximal attempts in each position to 80-90% maximal effort, then three maximal effort trials for each limb in each test position (I, Y, T), with 20 seconds rest between repetitions. For each repetition, subjects will be instructed to push against the plate as hard and as fast as possible for three seconds. Peak and mean force across the three attempts and positions will be recorded.

   Time frame: 24 months

3. Seated medicine ball toss

   The patient will start the test in the seated position with the legs extended in front of their body, and the head, shoulders and back firmly against a wall. They will then attempt a "chest pass" by throwing a 10 lbs. medicine ball as far as they can. Four trials will be completed with 30 sec rest between each trial. Maximum distance will be recorded and averaged, once adjusted for arm length (distance of the ball from the wall with the arm held at 90 degrees of flexion and full elbow extension).

   Time frame: 24 months

4. Posterior Shoulder Endurance Test

   The patient starts positioned in prone towards one edge of a plinth, with the arm held in 90o shoulder flexion, perpendicular to the floor. Holding a weight of 2% of total body weight, the patient will attempt to raise the weight to 90 degrees of horizontal abduction, holding for one second at this position before returning to the starting position (tempo of 30 bpm). The test is terminated when the patient is fatigued as indicated by 1) the inability to hold the mid position for one second and 2) using compensatory movements of the torso, or patient request to terminate.

   Time frame: 24 months

5. Plyometric Push up

   Participants will start in a push up position with each hand extended in front of the shoulders and positioned on an individual force plate. When cued, the participant will lower their body to the ground by flexing at the elbow until their sternum is 3 cm from the floor. They will then forcefully extend at the elbow and propel their body into the air above the plate. During landing, the subjects will be instructed to reduce the impact as much as possible and continue for two additional repetitions. Three repetitions will be completed. Peak ground reaction forces during impact, peak rate of force development (RFD) during the concentric phase will be averaged from the three repetitions and expressed as a limb symmetry index (injured/uninjured \* 100%).

   Time frame: 24 months

6. Single arm seated shot put

   The patient will start seated in an 18" chair without arm rests, with the legs positioned in front of their body, extended to rest straight onto an additional chair. The non-throwing arm will be placed across the chest, with a strap placed diagonally around the upper body to secure the subject to the chair. The patient will "put" (like shot put), and not "throw" (like baseball) the 6 lb. ball from shoulder height for maximal distance. Three maximal effort attempts will be recorded after a graded warm-up of four "puts" at 25, 50, 75 and 100% estimated effort. Thirty seconds rest will be provided between maximal attempts.

   Time frame: 24 months

Other outcomes

1. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)

   The ASES is a patient-reported upper extremity functional assessment tool and is scored out of a maximum 100 points, that represents maximum function and no pain.

   Time frame: 24 months

2. Single Assessment Numeric Evaluation (SANE) score

   Is a single question that asks patients to rate their affected shoulder as a percentage of normal, "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"

   Time frame: 24 months

3. EuroQol-5D (EQ-5D) + Visual Analog Scale (VAS)

   The EQ-5D is a PROM used to document overall wellness across five dimensions including mobility, self-care, usual activities, pain and anxiety/depression. A single value is calculated to represent the patients' health state relative to a specific population. The VAS asks participants: We would like you to indicate on this scale how good or bad your own health is TODAY, in your opinion. 100 means the best health you can imagine. 0 means worst health you can imagine.

   Time frame: 24 months

4. Shoulder activity scale (SAS)

   A patient reported outcome measure (PROM) where patients categorize the frequency (i.e. never, once a month, once a week, more than once a week, and daily) of certain activities of the upper extremity (i.e. carrying objects 8 lbs. or heavier by hand) and also identify whether they participate in either contact or overhead sports including the level of participation.

   Time frame: 24 months

5. Postoperative Pain and Medication Use

   Postoperative pain will be self-reported on a 100mm visual analogue scale (VAS) in a logbook. Medication type and quantity will also be documented. The Postoperative Pain and Medication Logbook has been previously used by the authors in an ACL population.

   Time frame: 3 weeks

6. Subjective Patient Outcome for Return to Sports (SPORTS)

   Evaluates the ability of an athlete to resume their sport at-pre-injury level of training or performance, and whether each is possible without or despite pain. Scored on a 10-point scale, where an inability to return to the same sport is scored as "0" and unlimited effort and performance without pain is a "10".

   Time frame: 24 months

7. Shoulder Instability Return to Sport (SIRSI)

   PROM of psychological readiness to return-to-sport (RTS), adapted from the previously validated ACL-RSI, that may highlight clinically important differences in patient's perceptions relative to RTS between the two procedures. The SIRSI asks participants 12 questions where they rate on a 10-point scale; "0" is not confident at all, and "10" is fully confident.

   Time frame: 24 months

8. Waterloo Handedness Questionnaire (WHQ)

   A series of 39 questions used to establish limb dominance, where questions 1-36 ask the participant to indicate their hand preference for the following activities by circling the appropriate response. If they always (i.e. 95% or more of the time) use one hand to perform the described activity, circle Ra or La (for right always or left always). If they usually (i.e. about 75% of the time) use one hand circle Ru or Lu, as appropriate. If they use both hands equally often (i.e. you use each hand about 50% of the time), circle Eq. Questions 37-39 are 'Yes" or "No" answers.

   Time frame: 24 months

9. Closed Kinetic Chain Upper Extremity Stability Test

   The patient assumes a standard push-up position with the middle of the hands positioned on a 1.5" piece of athletic tape, with 36" between each piece of tape. The patient then alternates lifting each hand to touch the opposite hand/tape as many times as possible within 15 seconds. Three trials will be completed and averaged. Thirty seconds rest will be provided between trials.

   Time frame: 24 months

Individual participant data

Plan to share: No — There is no plan to share IPD with other researchers.