OsteoarthritisEpoca H vs TNCT01288066
Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the "Epoca" System
A study testing Hemiarthroplasty and Total arthroplasty in people with Osteoarthritis, run by AO Innovation Translation Center at 4 sites in 3 countries.
Trial summary
The clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease, has not been answered yet in a randomized study with enough statistical power. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hemiarthroplasty and Total arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Sep 2011to Jun 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Primary or secondary omarthrosis (eg, rheumatoid arthritis, avascular head necrosis)
- Glenoid morphologic type A1, A2 or B1 according to Walch
- Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation
- Written informed consent
Who cannot join
- Preoperative:
- Posttraumatic omarthrosis
- Biconcave aspect of glenoid (Walch type B2)
- Retroversion of glenoid more than 25° (Walch type C)
- "Epoca Reko" prosthesis
- Humerus fractures
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- Patients with a severe systemic disease: class III-IV according to the American Society of Anaesthesiologists physical status classification (ASA)
- Substance abuse that would preclude reliable assessment
- Pregnancy
- Prisoners
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- Intraoperative:
- Full thickness tear of rotator cuff
- Indication for hemiarthroplasty only
- Indication for total arthroplasty only
- Intraoperative decision to use implants other than Epoca
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Universitätsklinikum Freiburg
Freiburg im Breisgau
Klinikum Region Hannover GmbH, Klinikum Agnes-Karll Laatzen
Laatzen, 30880
Sweden1 site
Universitetssjukhuset Ortopedicentrum i Östergötland
Linköping, 58185
About this study
Official title: A Randomized Multicenter Study Comparing the Effectiveness of Hemi Versus Total Shoulder Arthroplasty in Patients With a Degenerative Joint Disease
The clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease, has not been answered yet in a randomized study with enough statistical power. In this study, patients are randomly allocated to a treatment with a hemi- or total shoulder arthroplasty using implants of the Epoca system. The primary objective is the comparison of pain and function between the treatment groups after 5 years using the Constant score.
Read the detailed description
Shoulder arthroplasty is accepted as the treatment of choice for improved function with minimum pain in well-selected patients. A persistent discussion remains as to whether replacement of the glenoid (ie, total arthroplasty) should be performed. Possible advantages of glenoid replacement include decreased pain compared to hemiarthroplasty with a metal-on-bone articulation, increased stability due to the conforming glenoid component, and lateralization of the joint center providing improved range of motion and abduction strength. Potential complications of glenoid replacement are implant loosening and loss of glenoid bone stock.
If a hemiarthroplasty is performed, glenoid replacement and related complications are avoided. In addition, hemiarthroplasty requires less surgical time and is less expensive than total shoulder arthroplasty.
To date, there is no evidence to answer the clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease. In this study, both the stemmed Epoca humeral component (Epoca Stem) and the Epoca Resurfacing Head (Epoca RH) are included. While the stemmed prosthesis was developed both for nonreconstructable fractures and omarthroses, the humeral resurfacing head implant was designed specifically for use in degenerative diseases of the shoulder joint.
This randomized multicenter study aims to compare the efficacy of hemi versus total shoulder arthroplasty using Epoca RH or Epoca Stem in patients with degenerative joint diseases. The primary aim of the present study is to demonstrate that the Constant score assessing shoulder function and pain is higher in the patient group treated with total arthroplasty compared to the hemiarthroplasty group after 5 years. The secondary aims of the study are to assess differences in the Shoulder Pain and Disability Index (SPADI), duration of surgery, rates of local and general adverse events and relationship to the device or treatment under investigation, survivorship of the implants, and quality of life after 6 months, 1, 3 and 5 years between the treatment groups.
- Conditions
- Osteoarthritis
- Being tested
- Hemiarthroplasty, Total arthroplasty
- Keywords
- Shoulder, Total arthroplasty, Hemiarthroplasty, Resurfacing, Glenoid, Constant score
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemiarthroplastyProcedure or surgery
Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.
Total arthroplastyProcedure or surgery
Patients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.
| Study group | Role | What they receive |
|---|---|---|
| Hemiarthroplasty | Other | Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system. Receives: Procedure: Hemiarthroplasty |
| Total arthroplasty | Other | Patients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system. Receives: Procedure: Total arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Constant score assessment of shoulder function and pain
The primary outcome measure is the difference between the Constant score assessment of shoulder function and pain at baseline and 5 years after surgery. This difference is assessed for each individual patient.
Measured: Baseline to 5 years postsurgery
Secondary outcomes (6)
Constant score
Measured: 6 months, 1 year, 3 years
Shoulder Pain and Disability Index (SPADI)
Measured: 6 months, 1 year, 3 years, 5 years
Duration of surgery
Measured: 1-2 days
Numbers of adverse events
Measured: Baseline to 5 years follow-up
Survivorship of implants
Measured: Baseline to 5 years follow-up
Quality of life related to health
Quality of life is assessed using the Euroqol - 5 Dimensions (EQ-5D) questionnaire
Measured: Baseline, 6 months, 1 year, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2024
- Study completionJun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Collaborators
- Synthes GmbH
- Responsible party
- Sponsor
- Investigators
- Norbert Suedkamp, MD, Principal investigator, Universitätsklinikum Freiburg, Deutschland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288066
- Sponsor's protocol ID
- Epoca Hemi vs. Total 2011
- Acronym
- Epoca H vs T
- Status last verified
- Oct 2023
- First submitted
- 31 Jan 2011
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Study Comparing the Effectiveness of Hemi Versus Total Shoulder Arthroplasty in Patients With a Degenerative Joint Disease
- ClinicalTrials.gov ID
- NCT01288066
- Acronym / sponsor ID
- Epoca H vs T / Epoca Hemi vs. Total 2011
- Conditions
- Osteoarthritis
- Keywords
- Shoulder, Total arthroplasty, Hemiarthroplasty, Resurfacing, Glenoid, Constant score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Collaborators
- Synthes GmbH
- Study start
- Sep 2011
- Primary completion
- Jun 2024 (actual)
- Study completion
- Jun 2024 (actual)
- First posted
- 2 Feb 2011 (estimated)
- 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.
The clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease, has not been answered yet in a randomized study with enough statistical power. In this study, patients are randomly allocated to a treatment with a hemi- or total shoulder arthroplasty using implants of the Epoca system. The primary objective is the comparison of pain and function between the treatment groups after 5 years using the Constant score.
Detailed description
Shoulder arthroplasty is accepted as the treatment of choice for improved function with minimum pain in well-selected patients. A persistent discussion remains as to whether replacement of the glenoid (ie, total arthroplasty) should be performed. Possible advantages of glenoid replacement include decreased pain compared to hemiarthroplasty with a metal-on-bone articulation, increased stability due to the conforming glenoid component, and lateralization of the joint center providing improved range of motion and abduction strength. Potential complications of glenoid replacement are implant loosening and loss of glenoid bone stock.
If a hemiarthroplasty is performed, glenoid replacement and related complications are avoided. In addition, hemiarthroplasty requires less surgical time and is less expensive than total shoulder arthroplasty.
To date, there is no evidence to answer the clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease. In this study, both the stemmed Epoca humeral component (Epoca Stem) and the Epoca Resurfacing Head (Epoca RH) are included. While the stemmed prosthesis was developed both for nonreconstructable fractures and omarthroses, the humeral resurfacing head implant was designed specifically for use in degenerative diseases of the shoulder joint.
This randomized multicenter study aims to compare the efficacy of hemi versus total shoulder arthroplasty using Epoca RH or Epoca Stem in patients with degenerative joint diseases. The primary aim of the present study is to demonstrate that the Constant score assessing shoulder function and pain is higher in the patient group treated with total arthroplasty compared to the hemiarthroplasty group after 5 years. The secondary aims of the study are to assess differences in the Shoulder Pain and Disability Index (SPADI), duration of surgery, rates of local and general adverse events and relationship to the device or treatment under investigation, survivorship of the implants, and quality of life after 6 months, 1, 3 and 5 years between the treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemiarthroplasty | Other | Procedure: HemiarthroplastyPatients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system. |
| Total arthroplasty | Other | Procedure: Total arthroplastyPatients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years and older
- Primary or secondary omarthrosis (eg, rheumatoid arthritis, avascular head necrosis)
- Glenoid morphologic type A1, A2 or B1 according to Walch
- Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation
- Written informed consent
Key exclusion criteria (16 listed)
- Posttraumatic omarthrosis
- Biconcave aspect of glenoid (Walch type B2)
- Retroversion of glenoid more than 25° (Walch type C)
- "Epoca Reko" prosthesis
- Humerus fractures
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 |
|---|---|---|
| HemiarthroplastyPatients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease. | Procedure or surgery | Hemiarthroplasty |
| Total arthroplastyPatients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease. | Procedure or surgery | Total arthroplasty |
Primary outcome
The Constant score assessment of shoulder function and pain
Time frame: Baseline to 5 years postsurgery
The primary outcome measure is the difference between the Constant score assessment of shoulder function and pain at baseline and 5 years after surgery. This difference is assessed for each individual patient.
6 secondary outcomes
Constant score
Time frame: 6 months, 1 year, 3 years
Shoulder Pain and Disability Index (SPADI)
Time frame: 6 months, 1 year, 3 years, 5 years
Duration of surgery
Time frame: 1-2 days
Numbers of adverse events
Time frame: Baseline to 5 years follow-up
Survivorship of implants
Time frame: Baseline to 5 years follow-up
Quality of life related to health
Time frame: Baseline, 6 months, 1 year, 3 years, 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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.
Norbert Suedkamp, MD principal investigator
Universitätsklinikum Freiburg, Deutschland
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemiarthroplasty and Total arthroplasty in people with Osteoarthritis, run by AO Innovation Translation Center at 4 sites in 3 countries.
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 5 inclusion and 16 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: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria, Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Constant score assessment of shoulder function and pain (time frame: Baseline to 5 years postsurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.