Osteoarthritis of the ShoulderNCT03097406
Functional Outcome and Complications After Global Unite ® Prostheses
An observational study of Osteoarthritis of the Shoulder and Proximal Humeral Fracture, run by Herlev and Gentofte Hospital at 2 sites in Denmark.
Trial summary
This study aims to investigate the shoulder function of patients with osteoarthritis or a fracture of the upper extremity after surgery with the Global Unite shoulder system. The majority of fractures of the humerus are non-surgically treated, but for the complex cases where the fracture is irreparable (1), the… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis of the Shoulder, Proximal Humeral Fracture
- What is being tested?
- Global Unite hemiarthroplasty, Global Advantage and Global FX
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jan 2017to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The fracture patients will be included from the emergency rooms and outpatient visits at Herlev and Køge University Hospital. Patients are assessed by experienced shoulder surgeons before surgery. Osteoarthritis patients are assessed by outpatient visits to Herlev University Hospital. The fracture and osteoarthritis control groups are found in the hospitals' registries and are offered an inspection of the shoulder.
Who may be able to join
- Osteoarthritis patients:
- Pronounced osteoarthritis
- physician-assessed need of surgery
- Surgery at Herlev University Hospital
- Fracture patients:
- Luxation fractures
Show all 16Show fewer
- 4-part fractures
- Displaced 3-part fractures
- Headsplit fractures
- Treated at Herlev University Hospital or Køge University Hospital
- Control group:
- Surgery from 2013-2017
- Treated for osteoarthritis with Global Advantage
- Osteoarthritis surgery at Herlev University Hospital
- Treated with Global FX due to fracture of the proximal humerus
- Global FX treatment at Herlev or Køge University Hospital
Who cannot join
- Patients not living in Denmark
- Two-part fractures of the proximal humerus
- Patient without a Danish civil registration number
- Patients younger than 50
- Revision surgery
- Previous arthroplasty procedures in the same shoulder
- Deceased patients
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Herlev University Hospital
Herlev, Copenhagen, 2730
Køge University Hospital
Køge, 4600
About this study
Official title: Functional Outcome and Complications After Global Unite ® Prostheses in Osteoarthritis and Displaced Fractures of the Proximal Humerus.
This study aims to investigate the shoulder function of patients with osteoarthritis or a fracture of the upper extremity after surgery with the Global Unite shoulder system.
The majority of fractures of the humerus are non-surgically treated, but for the complex cases where the fracture is irreparable (1), the treatment choice is a shoulder prosthesis called a hemiarthroplasty. Hemiarthroplasty has been associated to less pain and more quality of life , (2,3) but no difference in range of motion is reported when compared to non-surgically treatment of complex humeral fractures. (2,3,4)
Read more
One of the important steps in surgery of a fractured humerus is the fixation of the bone fragments in an anatomically correct position as previous studies have shown that complications related to the fixation and healing of bone fragments occurred in 11 % of patients treated with a hemiarthroplasty . The Global Unite hemiarthroplasty introduces a new feature, which allows the surgeon to more closely attach the bone fragments.
Patients with osteoarthritis and fractures of the humerus will be included from two hospitals, Herlev and Køge University Hospital. A total of 88 patients, 44 osteoarthritis and 44 fracture patients, are included. The patients will be followed two years after surgery and will be seen a total of four times postoperatively, where the function of the shoulder will be examined by questionnaires concerning shoulder function and quality of life, by a motion examination and by x-ray. The outcome of these examinations will be compared to the functional outcome of patients that have received different shoulder prostheses for the same diagnoses at Herlev and Køge University Hospital. The patients will undergo two radiographic scans after surgery, to determine whether or not bone fragments remain in an anatomically correct position in the patients with a fracture of the proximal humerus. A special focus will be on the function of the shoulder in patients with bone fragments that are not in an anatomically correct position. Furthermore, complications and the need of reoperation were registered during the two-year follow-up period.
The aims of this study is to
- Determine the function of the shoulder in patients receiving the Global Unite prosthesis due to either osteoarthritis or fracture of the humerus.
- To compare these results with results from patients previously treated with a different prosthesis designs
- To determine the influence of the fixation of bone fragments in the postoperative function in fracture patients.
Read the detailed description
The study was based on data from Køge and Herlev University Hospital. All patients that fit the inclusion criteria and had an indication for shoulder replacement where included and the study started on the 1st of January 2017.
Aim
- To determine 2-year postoperative outcome, complications and revision rates in patients receiving a Global Unite
- To compare the postoperative outcome to patients from a in matched control group
- To determine the influence of tuberosity placement and migration on functional outcome in patients with a fracture of the proximal humerus.
The trauma mechanism of the fractures and health status of the patients were determined upon arrival. A preoperative CT-scan was performed in all fracture patients for preoperative planning. A CT-scan was also performed preoperatively in the osteoarthritis patients to determine the degree of bone degeneration. An x-ray was performed right after surgery, 3 months and 24 months postoperatively.
The patients included received a Global Unite hemiarthroplasty in the fracture situation and a Global Unite total shoulder in osteoarthritis patients. The patients received standardized postoperative analgesic treatment and physiotherapy rehabilitation and all patients had postoperative follow-up 3, 6 months, 1-year and 2-year after surgery. The outcome at the follow-up was determined by using Oxford Shoulder Score, Constant-Murley score, EQ-5-D questionnaire and Western Ontario Osteoarthritis of the Shoulder index
Factors like American Society of Anesthesiologists score, body-mass index, smoking, alcohol, medication and comorbidity were registered. Furthermore time from injury to surgery, surgery time, length of hospital stay, complications (osteonecrosis, infection, loosening), revision, discharge type, pain score and analgesia were reported. The preoperatively function was only registered for osteoarthritis patients.
The study was performed as a prospective cohort study with a historic control group. The fracture patients submitted for a Global Unite from February 2017 were compared to fracture patients receiving the Global FX at Herlev and Køge Hospital from 2013 to 2016 and the osteoarthritis patients receiving a Global Unite total shoulder were compared to patients receiving a Global Advantage at Herlev Hospital from 2013-2016. 44 patients were included in the control and the intervention groups, of both diagnoses, to obtain power of 80 % in power calculations based on Constant-Murley score. This equals a total of 88 patients in the intervention groups and 88 patients in the control groups. It was estimated that it would take 2 to 3 years to include osteoarthritis- and fracture-patients in this study.
All surgery was performed by 5 senior consultants at Herlev Hospital and 2 senior consultants at Køge Hospital. The postoperative functional outcome of patients in the first half of the study was compared to the outcome of patients in the last half to determine a possible learning curve. The follow-up was performed by one independent physician
- Being tested
- Global Unite hemiarthroplasty, Global Advantage, Global FX, Global Unite total shoulder arthroplasty
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Unite hemiarthroplastyProcedure or surgery
A hemiarthroplasty used for complex fractures of the proximal humerus.
Global AdvantageProcedure or surgery
A total shoulder prosthesis used for osteoarthritis
Global FXProcedure or surgery
A hemiarthroplasty used for complex fractures of the proximal humerus.
Global Unite total shoulder arthroplastyProcedure or surgery
A total shoulder prosthesis used for osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthritis group | Patients with osteoarthritis (2017-2019) at Herlev Hospital treated with Global Unite total shoulder arthroplasty Receives: Procedure: Global Unite total shoulder arthroplasty | |
| Osteoarthritis control group | Patients with osteoarthritis (2013-2016) at Herlev Hospital treated with a Global Advantage Receives: Procedure: Global Advantage | |
| Fracture group | Patients with a fracture of the proximal humerus (2017-2019) at Køge and Herlev Hospital treated with Global Unite hemiarthroplasty Receives: Procedure: Global Unite hemiarthroplasty | |
| Fracture control group | Patients with a fracture of the proximal humerus (2013-2016) at Køge and Herlev Hospital treated with Global FX hemiarthroplasty Receives: Procedure: Global FX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS))
The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients.
Measured: 3 months after surgery
Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS))
The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients.
Measured: 6 months after surgery
Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS))
The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients. . The outcome will be compared with outcome of patients that previously received Global FX or Global Advantage for fracture or osteoarthritis, respectively.
Measured: 12 months after surgery
Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS))
The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients. The outcome will be compared with outcome of patients that previously received Global FX or Global Advantage for fracture or osteoarthritis, respectively.
Measured: 24 months after surgery
Functional outcome (Constant-Murley Score (CMS))
CMS is used to measure the functional outcome for the patients.
Measured: 3 months after surgery
Functional outcome (Constant-Murley Score (CMS))
CMS is used to measure the functional outcome for the patients.
Measured: 6 months after surgery
Functional outcome (Constant-Murley Score (CMS))
CMS is used to measure the functional outcome for the patients.
Measured: 12 months after surgery
Functional outcome (Constant-Murley Score (CMS))
CMS is used to measure the functional outcome for the patients. The outcome will be compared with outcome of patients that previously received Global FX or Global Advantage for fracture or osteoarthritis, respectively
Measured: 24 months after surgery
Functional outcome (Oxford Shoulder Score (OSS))
The OSS questionnaire is used to measure the patient-reported functional outcome.
Measured: 3 months after surgery
Functional outcome (Oxford Shoulder Score (OSS))
The OSS questionnaire is used to measure the patient-reported functional outcome.
Measured: 6 months after surgery
Functional outcome (Oxford Shoulder Score (OSS))
The OSS questionnaire is used to measure the patient-reported functional outcome.
Measured: 12 months after surgery
Functional outcome (Oxford Shoulder Score (OSS))
The OSS questionnaire is used to measure the patient-reported functional outcome. The outcome will be compared with outcome of patients that previously received Global FX or Global Advantage for fracture or osteoarthritis, respectively
Measured: 24 months after surgery
Secondary outcomes (1)
Tuberosity migration or vanishing in fracture patients
A preoperative CT-scan will be performed and postoperative x-rays will be performed to determine whether or not the tuberosities have migrated or vanished in the fracture patients treated with Global Unite hemiarthroplasty
Measured: Baseline CT-scan, x-rays 3 and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Jan 2017
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, DePuy Synthes
- Responsible party
- Principal investigator, Alexander Amundsen, Herlev and Gentofte Hospital
- Investigators
- Alexander Amundsen, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097406
- Sponsor's protocol ID
- HERKOG2017
- Status last verified
- Aug 2019
- First submitted
- 15 Mar 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bryant D, Litchfield R, Sandow M, Gartsman GM, Guyatt G, Kirkley A. A comparison of pain, strength, range of motion, and functional outcomes after hemiarthroplasty and total shoulder arthroplasty in patients with osteoarthritis of the shoulder. A systematic review and meta-analysis. J Bone Joint Surg Am. 2005 Sep;87(9):1947-56. doi: 10.2106/JBJS.D.02854.
PubMed 16140808Olerud P, Ahrengart L, Ponzer S, Saving J, Tidermark J. Hemiarthroplasty versus nonoperative treatment of displaced 4-part proximal humeral fractures in elderly patients: a randomized controlled trial. J Shoulder Elbow Surg. 2011 Oct;20(7):1025-33. doi: 10.1016/j.jse.2011.04.016. Epub 2011 Jul 23.
PubMed 21783385den Hartog D, de Haan J, Schep NW, Tuinebreijer WE. Primary shoulder arthroplasty versus conservative treatment for comminuted proximal humeral fractures: a systematic literature review. Open Orthop J. 2010 Feb 17;4:87-92. doi: 10.2174/1874325001004020087.
PubMed 20309406Handoll HH, Ollivere BJ, Rollins KE. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2012 Dec 12;12:CD000434. doi: 10.1002/14651858.CD000434.pub3.
PubMed 23235575
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome and Complications After Global Unite ® Prostheses in Osteoarthritis and Displaced Fractures of the Proximal Humerus.
- ClinicalTrials.gov ID
- NCT03097406
- Acronym / sponsor ID
- HERKOG2017
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Zealand University Hospital, DePuy Synthes
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the shoulder function of patients with osteoarthritis or a fracture of the upper extremity after surgery with the Global Unite shoulder system.
The majority of fractures of the humerus are non-surgically treated, but for the complex cases where the fracture is irreparable (1), the treatment choice is a shoulder prosthesis called a hemiarthroplasty. Hemiarthroplasty has been associated to less pain and more quality of life , (2,3) but no difference in range of motion is reported when compared to non-surgically treatment of complex humeral fractures. (2,3,4)
One of the important steps in surgery of a fractured humerus is the fixation of the bone fragments in an anatomically correct position as previous studies have shown that complications related to the fixation and healing of bone fragments occurred in 11 % of patients treated with a hemiarthroplasty . The Global Unite hemiarthroplasty introduces a new feature, which allows the surgeon to more closely attach the bone fragments.
Patients with osteoarthritis and fractures of the humerus will be included from two hospitals, Herlev and Køge University Hospital. A total of 88 patients, 44 osteoarthritis and 44 fracture patients, are included. The patients will be followed two years after surgery and will be seen a total of four times postoperatively, where the function of the shoulder will be examined by questionnaires concerning shoulder function and quality of life, by a motion examination and by x-ray. The outcome of these examinations will be compared to the functional outcome of patients that have received different shoulder prostheses for the same diagnoses at Herlev and Køge University Hospital. The patients will undergo two radiographic scans after surgery, to determine whether or not bone fragments remain in an anatomically correct position in the patients with a fracture of the proximal humerus. A special focus will be on the function of the shoulder in patients with bone fragments that are not in an anatomically correct position. Furthermore, complications and the need of reoperation were registered during the two-year follow-up period.
The aims of this study is to
- Determine the function of the shoulder in patients receiving the Global Unite prosthesis due to either osteoarthritis or fracture of the humerus.
- To compare these results with results from patients previously treated with a different prosthesis designs
- To determine the influence of the fixation of bone fragments in the postoperative function in fracture patients.
Detailed description
The study was based on data from Køge and Herlev University Hospital. All patients that fit the inclusion criteria and had an indication for shoulder replacement where included and the study started on the 1st of January 2017.
Aim
- To determine 2-year postoperative outcome, complications and revision rates in patients receiving a Global Unite
- To compare the postoperative outcome to patients from a in matched control group
- To determine the influence of tuberosity placement and migration on functional outcome in patients with a fracture of the proximal humerus.
The trauma mechanism of the fractures and health status of the patients were determined upon arrival. A preoperative CT-scan was performed in all fracture patients for preoperative planning. A CT-scan was also performed preoperatively in the osteoarthritis patients to determine the degree of bone degeneration. An x-ray was performed right after surgery, 3 months and 24 months postoperatively.
The patients included received a Global Unite hemiarthroplasty in the fracture situation and a Global Unite total shoulder in osteoarthritis patients. The patients received standardized postoperative analgesic treatment and physiotherapy rehabilitation and all patients had postoperative follow-up 3, 6 months, 1-year and 2-year after surgery. The outcome at the follow-up was determined by using Oxford Shoulder Score, Constant-Murley score, EQ-5-D questionnaire and Western Ontario Osteoarthritis of the Shoulder index
Factors like American Society of Anesthesiologists score, body-mass index, smoking, alcohol, medication and comorbidity were registered. Furthermore time from injury to surgery, surgery time, length of hospital stay, complications (osteonecrosis, infection, loosening), revision, discharge type, pain score and analgesia were reported. The preoperatively function was only registered for osteoarthritis patients.
The study was performed as a prospective cohort study with a historic control group. The fracture patients submitted for a Global Unite from February 2017 were compared to fracture patients receiving the Global FX at Herlev and Køge Hospital from 2013 to 2016 and the osteoarthritis patients receiving a Global Unite total shoulder were compared to patients receiving a Global Advantage at Herlev Hospital from 2013-2016. 44 patients were included in the control and the intervention groups, of both diagnoses, to obtain power of 80 % in power calculations based on Constant-Murley score. This equals a total of 88 patients in the intervention groups and 88 patients in the control groups. It was estimated that it would take 2 to 3 years to include osteoarthritis- and fracture-patients in this study.
All surgery was performed by 5 senior consultants at Herlev Hospital and 2 senior consultants at Køge Hospital. The postoperative functional outcome of patients in the first half of the study was compared to the outcome of patients in the last half to determine a possible learning curve. The follow-up was performed by one independent physician
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis group | – | Procedure: Global Unite total shoulder arthroplastyPatients with osteoarthritis (2017-2019) at Herlev Hospital treated with Global Unite total shoulder arthroplasty |
| Osteoarthritis control group | – | Procedure: Global AdvantagePatients with osteoarthritis (2013-2016) at Herlev Hospital treated with a Global Advantage |
| Fracture group | – | Procedure: Global Unite hemiarthroplastyPatients with a fracture of the proximal humerus (2017-2019) at Køge and Herlev Hospital treated with Global Unite hemiarthroplasty |
| Fracture control group | – | Procedure: Global FXPatients with a fracture of the proximal humerus (2013-2016) at Køge and Herlev Hospital treated with Global FX hemiarthroplasty |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The fracture patients will be included from the emergency rooms and outpatient visits at Herlev and Køge University Hospital. Patients are assessed by experienced shoulder surgeons before surgery. Osteoarthritis patients are assessed by outpatient visits to Herlev University Hospital. The fracture and osteoarthritis control groups are found in the hospitals' registries and are offered an inspection of the shoulder.
Key inclusion criteria (16 listed)
- Pronounced osteoarthritis
- physician-assessed need of surgery
- Surgery at Herlev University Hospital
- Luxation fractures
- 4-part fractures
Key exclusion criteria (7 listed)
- Patients not living in Denmark
- Two-part fractures of the proximal humerus
- Patient without a Danish civil registration number
- Patients younger than 50
- Revision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global Unite hemiarthroplastyA hemiarthroplasty used for complex fractures of the proximal humerus. | Procedure or surgery | Fracture group |
| Global AdvantageA total shoulder prosthesis used for osteoarthritis | Procedure or surgery | Osteoarthritis control group |
| Global FXA hemiarthroplasty used for complex fractures of the proximal humerus. | Procedure or surgery | Fracture control group |
| Global Unite total shoulder arthroplastyA total shoulder prosthesis used for osteoarthritis | Procedure or surgery | Osteoarthritis group |
Primary outcome
Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS))
Time frame: 3 months after surgery
The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients.
Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS))
Time frame: 6 months after surgery
The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients.
Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS))
Time frame: 12 months after surgery
The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients. . The outcome will be compared with outcome of patients that previously received Global FX or Global Advantage for fracture or osteoarthritis, respectively.
Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS))
Time frame: 24 months after surgery
The WOOS questionnaire is used to measure the patient-reported functional outcome for the patients. The outcome will be compared with outcome of patients that previously received Global FX or Global Advantage for fracture or osteoarthritis, respectively.
Functional outcome (Constant-Murley Score (CMS))
Time frame: 3 months after surgery
CMS is used to measure the functional outcome for the patients.
Functional outcome (Constant-Murley Score (CMS))
Time frame: 6 months after surgery
CMS is used to measure the functional outcome for the patients.
Functional outcome (Constant-Murley Score (CMS))
Time frame: 12 months after surgery
CMS is used to measure the functional outcome for the patients.
Functional outcome (Constant-Murley Score (CMS))
Time frame: 24 months after surgery
CMS is used to measure the functional outcome for the patients. The outcome will be compared with outcome of patients that previously received Global FX or Global Advantage for fracture or osteoarthritis, respectively
Functional outcome (Oxford Shoulder Score (OSS))
Time frame: 3 months after surgery
The OSS questionnaire is used to measure the patient-reported functional outcome.
Functional outcome (Oxford Shoulder Score (OSS))
Time frame: 6 months after surgery
The OSS questionnaire is used to measure the patient-reported functional outcome.
Functional outcome (Oxford Shoulder Score (OSS))
Time frame: 12 months after surgery
The OSS questionnaire is used to measure the patient-reported functional outcome.
Functional outcome (Oxford Shoulder Score (OSS))
Time frame: 24 months after surgery
The OSS questionnaire is used to measure the patient-reported functional outcome. The outcome will be compared with outcome of patients that previously received Global FX or Global Advantage for fracture or osteoarthritis, respectively
1 secondary outcome
Tuberosity migration or vanishing in fracture patients
Time frame: Baseline CT-scan, x-rays 3 and 24 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 16140808Bryant D, Litchfield R, Sandow M, Gartsman GM, Guyatt G, Kirkley A. A comparison of pain, strength, range of motion, and functional outcomes after hemiarthroplasty and total shoulder arthroplasty in patients with osteoarthritis of the shoulder. A systematic review and meta-analysis. J Bone Joint Surg Am. 2005 Sep;87(9):1947-56. doi: 10.2106/JBJS.D.02854.
- Background: PubMed 21783385Olerud P, Ahrengart L, Ponzer S, Saving J, Tidermark J. Hemiarthroplasty versus nonoperative treatment of displaced 4-part proximal humeral fractures in elderly patients: a randomized controlled trial. J Shoulder Elbow Surg. 2011 Oct;20(7):1025-33. doi: 10.1016/j.jse.2011.04.016. Epub 2011 Jul 23.
- Background: PubMed 20309406den Hartog D, de Haan J, Schep NW, Tuinebreijer WE. Primary shoulder arthroplasty versus conservative treatment for comminuted proximal humeral fractures: a systematic literature review. Open Orthop J. 2010 Feb 17;4:87-92. doi: 10.2174/1874325001004020087.
- Background: PubMed 23235575Handoll HH, Ollivere BJ, Rollins KE. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2012 Dec 12;12:CD000434. doi: 10.1002/14651858.CD000434.pub3.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis of the Shoulder
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
Not yet recruiting
Clinical Evaluation of TrHCROSS® for Different Joints
Joint Osteoarthritis, Knee Osteoarthristis
RecruitingPhase 4
PRP for Glenohumeral Osteoarthritis
Shoulder Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Amundsen, MD principal investigator
University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Shoulder and Proximal Humeral Fracture, run by Herlev and Gentofte Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (Western Ontario Osteoarthritis of the Shoulder (WOOS)) (time frame: 3 months after surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03097406, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.