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

NCT03877315 | Unknown DMC

• 1 other identifier: REG-106-2018
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Pain; Shoulder Osteoarthritis; Shoulder Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Western Ontario Osteoarthritis of the Shoulder Score (WOOS)

  3 months after surgery

• Oxford Shoulder Score (OSS)

  3 and 12 months after surgery

• EQ-5D questionnaire

  3 and 12 months after surgery

Study Arms (2)

Stemmed

ACTIVE COMPARATOR

Subjects operated with stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System.

Device: Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System.

Non-Stemmed

ACTIVE COMPARATOR

Subjects operated with stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.

Device: Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.

Interventions

Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System. DEVICE

A total shoulder prosthesis used in treating glenohumeral osteoarthritis

Stemmed

Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System. DEVICE

A total shoulder prosthesis used in treating glenohumeral osteoarthritis

Non-Stemmed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous shoulder surgery that involves the humeral head and/or the glenoid cavity.
• 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.
• 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.
• Brachial plexus palsy.
• Patients with previous fractures around the shoulder (clavicle, scapula, and proximal humerus fractures).
• Patients with MRI scan-verified full thickness total tear of one or more of the rotator cuff tendons.
• Patients with CT scan-verified glenoid retroversion ≥ 20° that does not allow glenoid component fixation without bone graft or need an augmented glenoid component.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Hvidovre University Hospital: collaborator

Study Sites (1)

Zealand University Hospital

Køge, 4600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 31300025 DERIVED

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zaid Issa, MD

  Zealand University Hospital Koege

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to which implant type they are receive. This will be done by not sharing the operation chart files with the patient's online file records; the inserted shoulder prosthesis will be noted by a unique code in operation file, and the radiologist will be asked not to describe the post-operation x-ray controls. The primary investigator will conduct the blinded statistical analysis supervised by the biostatistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, shoulder and elbow surgeon.

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: August 1, 2019
• Primary Completion: February 28, 2022
• Study Completion: August 1, 2023
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)