Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumeral Osteoarthritis.

Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumeral Osteoarthritis: a Patient Blinded Randomized Clinical Trial

Stemless shoulder arthroplasty systems with uncemented metaphyseal fixation have been used in Europe for glenohumeral osteoarthritis since 2004. The stemless design has several theoretical advantages compared with the stemmed shoulder arthroplasty systems: restoring patients' anatomy, preserving humeral bone stock, and few complications in component removal if the need for a revision arthroplasty arises. The purpose of the study is to compare the short-term, patient-reported outcome of stemless and stemmed total shoulder arthroplasty.

Study Overview

• Status: Active, not recruiting
• Conditions: Shoulder Pain; Shoulder Osteoarthritis; Shoulder Arthritis
• Intervention / Treatment: Device: Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System.; Device: Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.

Detailed Description

Glenohumeral joint osteoarthritis is a common cause of shoulder pain, affecting up to one-third of patients older than 60 years. Surgical treatment is indicated for patients with glenohumeral arthritis who continue to experience significant symptoms despite an appropriate course of non-operative management. Shoulder arthroplasty accounts for the third most common joint replacement procedure after the hip and knee arthroplasty. Based on data from the National Patient Registry, The Statistical Department of the Danish National Board of Health, the use of primary shoulder replacement in Denmark increased from 12 replacements per 100,000 inhabitants in 2005 to 19 replacements per 100,000 inhabitants in 2015. Glenohumeral osteoarthritis is now the most common indication for shoulder arthroplasty in Denmark.

Many different shoulder arthroplasty designs are available on the market. The stemless shoulder arthroplasty system with uncemented metaphyseal fixation has been used in Europe for glenohumeral osteoarthritis since 2004. The indications for anatomical stemless TSA are the same as for anatomical stemmed TSA: osteoarthritis, rheumatoid arthritis, and post-traumatic osteoarthritis or osteonecrosis.

The contraindications for anatomical stemless TSA are acute proximal humerus fracture, inadequate metaphyseal bone stock, and rotator cuff insufficiency.

Stemless TSA has several theoretical advantages over stemmed TSA: restoring patients' anatomy (humeral shaft angle, humeral head diameter, and lateralization); preserving humeral bone stock, and few complications in component removal should the need of a revision arthroplasty arise. A recent review of 3,360 anatomical total shoulder arthroplasties found an overall complication rate of 10.3%. Periprosthetic fractures accounted for 6.7% and humeral component loosening for 1.4% of all complications. Complications related to the stemmed humeral component can be divided into intraoperative (malpositioning, false route, periprosthetic fracture) and postoperative (loosening, migration, disassembly, periprosthetic fracture, stem fracture) complications. When a revision is necessary because of infection or periprosthetic fracture, the removal of a well-fixed or cemented humeral component can be challenging and lead to bone damage.

Few outcome studies on stemless TSA are available. A recent review of 11 observational studies (published 2010-2016), incorporating a total of 929 patients, reported comparable short- and midterm functional outcomes between stemmed and stemless shoulder prosthesis. Otherwise, there are few well-conducted and adequately powered clinical studies.

The objective of this study is to increase knowledge about shoulder function after operation with anatomical TSA by comparing the patient-reported outcome after stemmed and stemless anatomical TSA for glenohumeral osteoarthritis.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients aged ≥ 18 years.
2. Patients have been referred to the Orthopedic Department or Zealand University Hospital, Koege or Hvidovre University Hospital for shoulder pain during the study period.
3. Patients have the ability to read trial information in Danish and give informed consent.
4. The diagnosis will be based on plain radiographs (at least two perpendicular views), reduction of joint space, and/or osteophyte formation.
5. Clinical presentation with pain at night and/or daily pain, pain in overhead activity, and consumption of pain medication.

Exclusion Criteria:

1. Previous shoulder surgery that involves the humeral head and/or the glenoid cavity.
2. Patients with alcohol or drug abuse problems that can compromise rehabilitation and follow-up appointments as assessed by the recruiting surgeon at the first visit.
3. Patients unable to understand instructions in Danish, follow the rehabilitation protocol, or answer the questionnaires because of physical or cognitive inabilities as evaluated by the recruiting surgeon at the first visit.
4. Brachial plexus palsy.
5. Patients with previous fractures around the shoulder (clavicle, scapula, and proximal humerus fractures).
6. Patients with MRI scan-verified full thickness total tear of one or more of the rotator cuff tendons.
7. Patients with CT scan-verified glenoid retroversion ≥ 20° that does not allow glenoid component fixation without bone graft or need an augmented glenoid component.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stemmed; Subjects operated with stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System.	Device: Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System.; A total shoulder prosthesis used in treating glenohumeral osteoarthritis
Active Comparator: Non-Stemmed; Subjects operated with stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.	Device: Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.; A total shoulder prosthesis used in treating glenohumeral osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario Osteoarthritis of the Shoulder Score (WOOS)	The WOOS is a patient-administered, disease-specific ques¬tionnaire for measurement of the quality of life of patients with osteoarthritis. It provides scores for four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions. Patients answer each question using the visual analogue scale. The WOOS score is calculated by measuring the distance from the left side of the line and calculating the possible score ranging from 0 to 100 (recorded to the nearest 0.5 mm.) It consists of 19 questions, and the total score ranges from 0 to 1900. A maximum score of 1900 signifies that the patient has an extreme decrease in shoulder-related quality of life, whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life. The questionnaire has been translated into Danish and validated and tested on patients with shoulder osteoarthritis.	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario Osteoarthritis of the Shoulder Score (WOOS)		3 months after surgery
Oxford Shoulder Score (OSS)	Oxford Shoulder Score (OSS) is a measurement tool for the assessment of outcomes of shoulder surgery. It has been tested and validated in patients with primary or secondary osteoarthritis. The OSS is a 12-item questionnaire, with each item scored from 0-4; thus, the overall score is the sum of the scores received for individual questions. This results in a continuous score ranging from 0 (most severe symptoms) to 48 (least severe symptoms). For simplicity of presentation, the raw scores will be converted to a percentage of the maximum score. We will use a validated Danish version.	3 and 12 months after surgery
EQ-5D questionnaire	The EQ-5D, the health status component of the EuroQol assessment (EuroQol Group, Rotterdam, The Netherlands), is a generic instrument for describing and evaluating health-related quality of life. The EuroQol instrument has been designed for self-completion by the respondent. The EQ-5D is a descriptive system comprising five dimensions in each of which the respondents describe their health state: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The patient choose one of five levels for each dimension, and thus a five-digit number (EuroQol Group 1990) can define the resulting health state. We received permission to use the Danish version (permission ID number 27296).	3 and 12 months after surgery

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: Hvidovre University Hospital
• Investigators: Principal Investigator: Zaid Issa, MD, Zealand University Hospital Koege

Publications and helpful links

General Publications

• Issa Z, Rasmussen JV, Petersen JK, Schantz K, Brorson S. Patient-reported outcome after stemmed versus stemless total shoulder arthroplasty for glenohumeral osteoarthritis: a patient-blinded randomized clinical trial. Trials. 2019 Jul 12;20(1):427. doi: 10.1186/s13063-019-3535-9.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): February 28, 2022
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Arthralgia; Osteoarthritis; Shoulder Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Cytochrome P-450 CYP1A2 Inhibitors; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: REG-106-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes