Health TrialsbyHealthPanel

Prophylactic Conjoint Tendon Lengthening During Reverse Shoulder Arthroplasty Outcomes

ConditionOsteoarthritis Shoulder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNickolas Garbis

About this trial

Some patients may experience persistent pain in the front of their shoulder after reverse shoulder replacement. One of the possible reasons for this is that the surgery causes a change in the alignment of the shoulder joint, which may cause increased tension and compression on one of the biceps tendon called the conjoint tendon. The purpose of this study is to evaluate whether conjoint tendon lengthening, a surgical procedure that involves cutting and lengthening the conjoint tendon in order to reduce tension and compression, is able to prevent or reduce the risk of anterior shoulder pain at one year after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who are at least 18 years old undergoing primary reverse total shoulder arthroplasty

Operations that occur at Loyola University Medical Center (Maywood, IL), Loyola Ambulatory Surgery Center (Maywood, IL), or Gottlieb Memorial Hospital

Disqualifiers

Patients younger than 18 years old

Patients who had prior coracoid transfer procedure

Patients who are undergoing revision surgery from a prior arthroplasty

Current pregnancy As per standard protocol with all surgeries, a urine pregnancy test is performed prior to surgery. If positive, the surgery will be cancelled and the patient will be excluded from the research study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prophylactic Conjoint Tendon Lengthening

    Procedure/Surgery

    During a standard reverse shoulder arthroplasty procedure, the conjoint tendon will be incised and lengthened prophylactically

  • Standard Reverse Shoulder Arthroplasty

    Procedure/Surgery

    A standard reverse shoulder arthroplasty procedure will be performed

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

American Society of Shoulder and Elbow Surgeons (ASES) Score

The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. The higher the points the better the outcome.

Time frame
From enrollment to the end of treatment at 12 months

Secondary outcomes

1

Visual Analog Scale (VAS) Pain Score

The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10).

Time frame
From enrollment to the end of treatment at 12 months
2

The Shoulder Pain and Disability Index (SPADI)

The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with ADLs requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. The patient is instructed to choose the number that best describes their level of pain and extent of difficulty using the involved shoulder. The pain scale is summed up to a total of 50 while the disability scale sums up to 80. The total SPADI score is expressed as a percentage. A score of 0 indicates best 100 indicates worst. A higher score shows more disability.

Time frame
From enrollment to end of treatment at 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nickolas Garbis

Lead sponsor

Loyola University

Sponsor institution

Loyola University School of Medicine

Collaborator

Source ClinicalTrials.gov
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