Arthritis, RheumatoidPhase 2NCT00463424
Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis
A Phase 2 study testing NeuFlex metacarpophalangeal implant and Swanson metacarpophalangeal implant in people with Arthritis, Rheumatoid, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The main hypotheses for this study are as follows: 1. The use of NeuFlex implant results in flexion in the fourth and fifth MP joints that is at least 10 degrees greater than with teh use of the Swanson implant. 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- NeuFlex metacarpophalangeal implant and Swanson metacarpophalangeal implant
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2000to Aug 2005
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- rheumatoid arthritis
- primary metacarpophalangeal arthroplasty of all 4 digits
Who cannot join
- diagnosis of other connective tissue disorder (e.g. SLE, MCTD)
- previous surgery of MP joints
- revision metacarpophalangeal arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis: a Prospective Randomized Controlled Clinical Trial
The main hypotheses for this study are as follows:
- The use of NeuFlex implant results in flexion in the fourth and fifth MP joints that is at least 10 degrees greater than with teh use of the Swanson implant.
- The use of the NeuFlex implant is associated with a significantly (2.5 kg or more) greater grip strength than with the use of the Swanson implant.
Read the detailed description
Many studies have evaluated metacarpophalangeal joint (MP) range of motion following Swanson arthroplasty. These studies report that overall MP flexion is restricted postoperatively. They do not usually report individual range of motion values for each digit. Therefore one cannot identify if the degree of MP flexion restriction differs by digit.
We, and others, have observed that MP flexion is particularly restricted in the ring and litter finger following Swanson arthroplasty.
There is a new implant (NeuFlex), which instead of being introduced in full extension, like the Swanson implant, has a resting position of 30 degrees of flexion. As MP flexion is particularly restricted in the ring and little finger, an implant that by design encourages flexion may be helpful. A need exists to establish if the use of the NeuFlex implant produces greater MP flexion in the ring and little finger where restricted flexion has been identified as a problem.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- NeuFlex metacarpophalangeal implant, Swanson metacarpophalangeal implant
- Keywords
- Metacarpophalangeal Joint, Arthroplasty, Replacement, Range of Motion, Articular, Randomized Controlled Trials, Swanson, NeuFlex
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuFlex metacarpophalangeal implantDevice
Swanson metacarpophalangeal implantDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum active postoperative MP flexion
Secondary outcomes (6)
Maximum active postoperative MP extension
Maximum active postoperative MP arc of motion
Ulnar drift
Jamar grip strength
Sollerman Hand Function Score
Michigan Hand Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startOct 2000
- Study completionAug 2005
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 Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics, Stryker Trauma and Extremities
- Investigators
- Earl R Bogoch, MD, Principal investigator, St. Michael's Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463424
- Sponsor's protocol ID
- REB#2K-049C
- Status last verified
- Apr 2007
- First submitted
- 19 Apr 2007
- Last updated
- 20 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Delaney R, Trail IA, Nuttall D. A comparative study of outcome between the Neuflex and Swanson metacarpophalangeal joint replacements. J Hand Surg Br. 2005 Feb;30(1):3-7. doi: 10.1016/j.jhsb.2004.10.013.
PubMed 15620484Erdogan A, Weiss AP. [NeuFlex Silastic implant in metacarpophalangeal joint arthroplasty]. Orthopade. 2003 Sep;32(9):789-93. doi: 10.1007/s00132-003-0524-0. German.
PubMed 14508644Joyce TI, Unsworth A. NeuFlex metacarpophalangeal prostheses tested in vitro. Proc Inst Mech Eng H. 2005;219(2):105-10. doi: 10.1243/095441105X9192.
PubMed 15819481Weiss AP, Moore DC, Infantolino C, Crisco JJ, Akelman E, McGovern RD. Metacarpophalangeal joint mechanics after 3 different silicone arthroplasties. J Hand Surg Am. 2004 Sep;29(5):796-803. doi: 10.1016/j.jhsa.2004.04.023.
PubMed 15465227
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis: a Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00463424
- Acronym / sponsor ID
- REB#2K-049C
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Metacarpophalangeal Joint, Arthroplasty, Replacement, Range of Motion, Articular, Randomized Controlled Trials, Swanson, NeuFlex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics, Stryker Trauma and Extremities
- Study start
- Oct 2000
- Study completion
- Aug 2005 (actual)
- First posted
- 20 Apr 2007 (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 main hypotheses for this study are as follows:
- The use of NeuFlex implant results in flexion in the fourth and fifth MP joints that is at least 10 degrees greater than with teh use of the Swanson implant.
- The use of the NeuFlex implant is associated with a significantly (2.5 kg or more) greater grip strength than with the use of the Swanson implant.
Detailed description
Many studies have evaluated metacarpophalangeal joint (MP) range of motion following Swanson arthroplasty. These studies report that overall MP flexion is restricted postoperatively. They do not usually report individual range of motion values for each digit. Therefore one cannot identify if the degree of MP flexion restriction differs by digit.
We, and others, have observed that MP flexion is particularly restricted in the ring and litter finger following Swanson arthroplasty.
There is a new implant (NeuFlex), which instead of being introduced in full extension, like the Swanson implant, has a resting position of 30 degrees of flexion. As MP flexion is particularly restricted in the ring and little finger, an implant that by design encourages flexion may be helpful. A need exists to establish if the use of the NeuFlex implant produces greater MP flexion in the ring and little finger where restricted flexion has been identified as a problem.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- rheumatoid arthritis
- primary metacarpophalangeal arthroplasty of all 4 digits
Key exclusion criteria (3 listed)
- diagnosis of other connective tissue disorder (e.g. SLE, MCTD)
- previous surgery of MP joints
- revision metacarpophalangeal arthroplasty
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 |
|---|---|---|
| NeuFlex metacarpophalangeal implant | Device | – |
| Swanson metacarpophalangeal implant | Device | – |
Primary outcome
Maximum active postoperative MP flexion
6 secondary outcomes
Maximum active postoperative MP extension
Maximum active postoperative MP arc of motion
Ulnar drift
Jamar grip strength
Sollerman Hand Function Score
Michigan Hand Questionnaire
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 20 Apr 2007.
- Background: PubMed 15620484Delaney R, Trail IA, Nuttall D. A comparative study of outcome between the Neuflex and Swanson metacarpophalangeal joint replacements. J Hand Surg Br. 2005 Feb;30(1):3-7. doi: 10.1016/j.jhsb.2004.10.013.
- Background: PubMed 14508644Erdogan A, Weiss AP. [NeuFlex Silastic implant in metacarpophalangeal joint arthroplasty]. Orthopade. 2003 Sep;32(9):789-93. doi: 10.1007/s00132-003-0524-0. German.
- Background: PubMed 15819481Joyce TI, Unsworth A. NeuFlex metacarpophalangeal prostheses tested in vitro. Proc Inst Mech Eng H. 2005;219(2):105-10. doi: 10.1243/095441105X9192.
- Background: PubMed 15465227Weiss AP, Moore DC, Infantolino C, Crisco JJ, Akelman E, McGovern RD. Metacarpophalangeal joint mechanics after 3 different silicone arthroplasties. J Hand Surg Am. 2004 Sep;29(5):796-803. doi: 10.1016/j.jhsa.2004.04.023.
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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.
Earl R Bogoch, MD principal investigator
St. Michael's Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NeuFlex metacarpophalangeal implant and Swanson metacarpophalangeal implant in people with Arthritis, Rheumatoid, run by Unity Health Toronto 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 3 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 20 Apr 2007. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Maximum active postoperative MP flexion. 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 NCT00463424, 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 20 Apr 2007.