OsteoarthritisPhase 3NCT00158418
Cemented vs. Non-Cemented TSA for OA of the Shoulder
A Phase 3 study testing Cemented Humeral Stem and Uncemented Humeral Stem in people with Osteoarthritis, run by Fowler Kennedy Sport Medicine Clinic at 1 site in Canada.
Trial summary
The purpose of the study is to investigate the fixation of the humeral component in total shoulder arthroplasty for primary osteoarthritis of the glenohumeral joint.Our hypothesis is that uncemented fixation of the humerus will result in better disease-specific quality of life, decreased incidence of radiographic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Cemented Humeral Stem and Uncemented Humeral Stem
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2002to Aug 2008
- Phase
- Phase 3
- 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
- Primary osteoarthritis of the shoulder of grade III or higher (Kellgren and Lawrence modified for the shoulder
- Patients who have failed standard conservative management of their shoulder osteoarthritis
Who cannot join
- Patients with secondary OA resulting from major joint trauma, infection, avascular necrosis, cuff tear arthropathy, chronic dislocation, massive rotator cuff tear, inflammatory arthropathy, Charcot's arthropathy or previous shoulder surgery (other than arthroscopic debridement)
- Patients with preoperative CT scans of the shoulder which show insufficient glenoid bone stock that would not allow for implantation of a glenoid prosthesis
- Active joint or systemic infection
- Significant muscle paralysis
- Major medical illness (life expectancy less then 2yrs or unacceptably high operative risk)
- Unable to speak or read English/French
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cemented Versus Uncemented Fixation of Humeral Components in Total Shoulder Arthroplasty for Osteoarthritis of the Shoulder
The purpose of the study is to investigate the fixation of the humeral component in total shoulder arthroplasty for primary osteoarthritis of the glenohumeral joint.Our hypothesis is that uncemented fixation of the humerus will result in better disease-specific quality of life, decreased incidence of radiographic loosening, decrease operative time and no increase in complications.
Read the detailed description
Currently, cement fixation of the humeral component is recommended as the standard of care and review of the literature indicates that this fixation is associated with a low complication rate. Uncemented fixation is promising in its potential to provide long-term, stable fixation yet comparative results to cemented stems are not available at this time.
Despite an absence of data to support their use, there has been an exponential increase in the use of uncemented humeral component fixation in shoulder arthroplasty. This push may be dictated by the desire to reduce operative time in an attempt to cut surgical expenses. This goal is particularly highlighted by the efforts of government and third party bodies to maximize return on limited funds. There is no conclusive clinical data at this time to suggest that uncemented fixation yields results that are better than cemented fixation in the shoulder.
This multi-centre, prospective, randomized double blinded clinical trial will compare cemented versus uncemented/tissue-ingrowth fixation of the humeral component in total shoulder arthroplasty. Patients are recruited from 10 centres across Canada by surgeons with extensive experience in total shoulder arthroplasty. Patients will be randomized to receive either a cemented or uncemented humeral stem. All other variables will be controlled for.
The main evaluation of patient outcome is disease-specific quality of life. Validated tools evaluating shoulder function are being used for this purpose, as required by various societies. These include the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), the most responsive; Constant, preferred by European investigators; American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment and Shoulder Score Index, preferred by the ASES. Overall global health status is measured using the SF-36. Several secondary outcomes are monitored for during the post-operative course. These are: shoulder function, radiographic evaluation of component fixation, operative time and the incidence of revision surgery and complications.
- Conditions
- Osteoarthritis
- Being tested
- Cemented Humeral Stem, Uncemented Humeral Stem
- Keywords
- osteoarthritis, shoulder, randomized trial, cement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cemented Humeral StemProcedure or surgery
Uncemented Humeral StemProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales.
the Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
the Constant Score
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form.
Short Form-12
Secondary outcomes (2)
the evaluation of radiolucent lines indicative of implant loosening
the incidence of revision surgery complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Fowler Kennedy Sport Medicine Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Investigators
- Robert B Litchfield, MD, FRCSC, Principal investigator, Fowler Kennedy Sport Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158418
- Sponsor's protocol ID
- FKSMC-CIHR-2
- Other IDs
- UCT-137451
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 29 Jan 2009
- Results posted
- No
Publications
Barrack RL, Castro F, Guinn S. Cost of implanting a cemented versus cementless femoral stem. J Arthroplasty. 1996 Jun;11(4):373-6. doi: 10.1016/s0883-5403(96)80025-8.
PubMed 8792242Brems JJ. Rehabilitation following total shoulder arthroplasty. Clin Orthop Relat Res. 1994 Oct;(307):70-85.
PubMed 7924050Brenner BC, Ferlic DC, Clayton ML, Dennis DA. Survivorship of unconstrained total shoulder arthroplasty. J Bone Joint Surg Am. 1989 Oct;71(9):1289-96.
PubMed 2793880Brown DD, Friedman RJ. Postoperative rehabilitation following total shoulder arthroplasty. Orthop Clin North Am. 1998 Jul;29(3):535-47. doi: 10.1016/s0030-5898(05)70027-4.
PubMed 9706298Cameron B, Galatz L, Williams GR Jr. Factors affecting the outcome of total shoulder arthroplasty. Am J Orthop (Belle Mead NJ). 2001 Aug;30(8):613-23.
PubMed 11520017Cofield RH, Daly PJ. Total shoulder arthroplasty with a tissue-ingrowth glenoid component. J Shoulder Elbow Surg. 1992 Mar;1(2):77-85. doi: 10.1016/S1058-2746(09)80124-9. Epub 2009 Feb 19.
PubMed 22959043Cofield RH. Total shoulder arthroplasty with the Neer prosthesis. J Bone Joint Surg Am. 1984 Jul;66(6):899-906. doi: 10.2106/00004623-198466060-00010.
PubMed 6736090Cofield RH. Uncemented total shoulder arthroplasty. A review. Clin Orthop Relat Res. 1994 Oct;(307):86-93.
PubMed 7924051Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
PubMed 3791738Cuomo F, Checroun A. Avoiding pitfalls and complications in total shoulder arthroplasty. Orthop Clin North Am. 1998 Jul;29(3):507-18. doi: 10.1016/s0030-5898(05)70025-0.
PubMed 9706296Fenlin JM Jr, Frieman BG. Indications, technique, and results of total shoulder arthroplasty in osteoarthritis. Orthop Clin North Am. 1998 Jul;29(3):423-34. doi: 10.1016/s0030-5898(05)70018-3.
PubMed 9706289Gartsman GM, Russell JA, Gaenslen E. Modular shoulder arthroplasty. J Shoulder Elbow Surg. 1997 Jul-Aug;6(4):333-9. doi: 10.1016/s1058-2746(97)90000-8.
PubMed 9285872Havig MT, Kumar A, Carpenter W, Seiler JG 3rd. Assessment of radiolucent lines about the glenoid. An in vitro radiographic study. J Bone Joint Surg Am. 1997 Mar;79(3):428-32.
PubMed 9070534Hawkins RJ, Bell RH, Jallay B. Total shoulder arthroplasty. Clin Orthop Relat Res. 1989 May;(242):188-94.
PubMed 2706849KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
PubMed 13498604
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cemented Versus Uncemented Fixation of Humeral Components in Total Shoulder Arthroplasty for Osteoarthritis of the Shoulder
- ClinicalTrials.gov ID
- NCT00158418
- Acronym / sponsor ID
- FKSMC-CIHR-2
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, shoulder, randomized trial, cement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Fowler Kennedy Sport Medicine ClinicUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Aug 2002
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 12 Sep 2005 (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 purpose of the study is to investigate the fixation of the humeral component in total shoulder arthroplasty for primary osteoarthritis of the glenohumeral joint.Our hypothesis is that uncemented fixation of the humerus will result in better disease-specific quality of life, decreased incidence of radiographic loosening, decrease operative time and no increase in complications.
Detailed description
Currently, cement fixation of the humeral component is recommended as the standard of care and review of the literature indicates that this fixation is associated with a low complication rate. Uncemented fixation is promising in its potential to provide long-term, stable fixation yet comparative results to cemented stems are not available at this time.
Despite an absence of data to support their use, there has been an exponential increase in the use of uncemented humeral component fixation in shoulder arthroplasty. This push may be dictated by the desire to reduce operative time in an attempt to cut surgical expenses. This goal is particularly highlighted by the efforts of government and third party bodies to maximize return on limited funds. There is no conclusive clinical data at this time to suggest that uncemented fixation yields results that are better than cemented fixation in the shoulder.
This multi-centre, prospective, randomized double blinded clinical trial will compare cemented versus uncemented/tissue-ingrowth fixation of the humeral component in total shoulder arthroplasty. Patients are recruited from 10 centres across Canada by surgeons with extensive experience in total shoulder arthroplasty. Patients will be randomized to receive either a cemented or uncemented humeral stem. All other variables will be controlled for.
The main evaluation of patient outcome is disease-specific quality of life. Validated tools evaluating shoulder function are being used for this purpose, as required by various societies. These include the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), the most responsive; Constant, preferred by European investigators; American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment and Shoulder Score Index, preferred by the ASES. Overall global health status is measured using the SF-36. Several secondary outcomes are monitored for during the post-operative course. These are: shoulder function, radiographic evaluation of component fixation, operative time and the incidence of revision surgery and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary osteoarthritis of the shoulder of grade III or higher (Kellgren and Lawrence modified for the shoulder
- Patients who have failed standard conservative management of their shoulder osteoarthritis
Key exclusion criteria (8 listed)
- Patients with secondary OA resulting from major joint trauma, infection, avascular necrosis, cuff tear arthropathy, chronic dislocation, massive rotator cuff tear, inflammatory arthropathy, Charcot's arthropathy or previous shoulder surgery (other than arthroscopic debridement)
- Patients with preoperative CT scans of the shoulder which show insufficient glenoid bone stock that would not allow for implantation of a glenoid prosthesis
- Active joint or systemic infection
- Significant muscle paralysis
- Major medical illness (life expectancy less then 2yrs or unacceptably high operative risk)
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 |
|---|---|---|
| Cemented Humeral Stem | Procedure or surgery | – |
| Uncemented Humeral Stem | Procedure or surgery | – |
Primary outcome
disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales.
the Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
the Constant Score
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form.
Short Form-12
2 secondary outcomes
the evaluation of radiolucent lines indicative of implant loosening
the incidence of revision surgery complications
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 29 Jan 2009.
- Background: PubMed 8792242Barrack RL, Castro F, Guinn S. Cost of implanting a cemented versus cementless femoral stem. J Arthroplasty. 1996 Jun;11(4):373-6. doi: 10.1016/s0883-5403(96)80025-8.
- Background: PubMed 7924050Brems JJ. Rehabilitation following total shoulder arthroplasty. Clin Orthop Relat Res. 1994 Oct;(307):70-85.
- Background: PubMed 2793880Brenner BC, Ferlic DC, Clayton ML, Dennis DA. Survivorship of unconstrained total shoulder arthroplasty. J Bone Joint Surg Am. 1989 Oct;71(9):1289-96.
- Background: PubMed 9706298Brown DD, Friedman RJ. Postoperative rehabilitation following total shoulder arthroplasty. Orthop Clin North Am. 1998 Jul;29(3):535-47. doi: 10.1016/s0030-5898(05)70027-4.
- Background: PubMed 11520017Cameron B, Galatz L, Williams GR Jr. Factors affecting the outcome of total shoulder arthroplasty. Am J Orthop (Belle Mead NJ). 2001 Aug;30(8):613-23.
- Background: PubMed 22959043Cofield RH, Daly PJ. Total shoulder arthroplasty with a tissue-ingrowth glenoid component. J Shoulder Elbow Surg. 1992 Mar;1(2):77-85. doi: 10.1016/S1058-2746(09)80124-9. Epub 2009 Feb 19.
- Background: PubMed 6736090Cofield RH. Total shoulder arthroplasty with the Neer prosthesis. J Bone Joint Surg Am. 1984 Jul;66(6):899-906. doi: 10.2106/00004623-198466060-00010.
- Background: PubMed 7924051Cofield RH. Uncemented total shoulder arthroplasty. A review. Clin Orthop Relat Res. 1994 Oct;(307):86-93.
- Background: PubMed 3791738Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
- Background: PubMed 9706296Cuomo F, Checroun A. Avoiding pitfalls and complications in total shoulder arthroplasty. Orthop Clin North Am. 1998 Jul;29(3):507-18. doi: 10.1016/s0030-5898(05)70025-0.
- Background: PubMed 9706289Fenlin JM Jr, Frieman BG. Indications, technique, and results of total shoulder arthroplasty in osteoarthritis. Orthop Clin North Am. 1998 Jul;29(3):423-34. doi: 10.1016/s0030-5898(05)70018-3.
- Background: PubMed 9285872Gartsman GM, Russell JA, Gaenslen E. Modular shoulder arthroplasty. J Shoulder Elbow Surg. 1997 Jul-Aug;6(4):333-9. doi: 10.1016/s1058-2746(97)90000-8.
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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.
Robert B Litchfield, MD, FRCSC principal investigator
Fowler Kennedy Sport Medicine Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cemented Humeral Stem and Uncemented Humeral Stem in people with Osteoarthritis, run by Fowler Kennedy Sport Medicine Clinic at 1 site in Canada.
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 2 inclusion and 8 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 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales.. The study lists 5 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 NCT00158418, which also lists 35 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 29 Jan 2009.