Wrist OsteoarthritisNCT02510326
Evaluation of Motion in the Arthritic Wrist Joint
An observational study of Wrist Osteoarthritis, run by Clalit Health Services at 1 site in Israel.
Trial summary
The scaphotrapeziotrapezoid (STT) joint is a dome shaped joint in the radial wrist that is important in transfer of load from the thumb and radial hand to the scaphoid and the radioscaphoid and scaphocapitate joints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Osteoarthritis
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Five patients being treated by the PI that have a diagnosis or a finding of STT joint arthritis stage 3 on X-ray will be included in the study.
Who may be able to join
- Patients with STT joint osteoarthritis(OA) - stage 3
- Exclusion Criteria: incomplete radiographs, early stage STT OA
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The scaphotrapeziotrapezoid (STT) joint is a dome shaped joint in the radial wrist that is important in transfer of load from the thumb and radial hand to the scaphoid and the radioscaphoid and scaphocapitate joints. Arthritis in this joint is the second most common degenerative arthritis in the wrist, reported in 15% of wrist radiographs. The true incidence of arthritis in the STT joint however is unknown though we assume that most cases of arthritis are not clinically significant. Furthermore, the clinical and biomechanical significance of arthritis in this joint is unclear. The investigators' clinical impression is that the incidence of STT joint arthritis is inversely related to that of radiocarpal joint arthritis. In an ongoing study, we are examining the relationship between STT joint arthritis and radiocarpal joint arthritis on radiographs.
We suggest that STT joint arthritis alters the biomechanics of the wrist by limiting movement of the scaphoid within the STT joint thereby protecting the wrist from radiocarpal arthritis by limiting instability of the scaphoid.
Read more
The specific aims of this pilot study are to evaluate the movement of the arthritic scaphoid within the STT joint using a computer-generated model based on CT scan of the wrist and to compare this model with the already established model of the normal STT joint.
The investigators' hypothesis is that there is significantly less motion in the arthritic STT joint.
Read the detailed description
Because it is poorly understood, the treatment of wrist arthritis remains limited to suboptimal salvage operations and wrist fusions. These are surgeries, which greatly limit function. This study is designed to evaluate arthritis of the STT joint and its affect on arthritis in other parts of the wrist. This may improve the understanding of wrist mechanics enabling us to develop better treatment of wrist arthritis. STT joint arthrodesis is an accepted surgery whose indications may be influenced by information obtained in this study.
Five patients being treated by the PI that have a diagnosis or a finding of STT joint arthritis stage 3 on X-ray will be included in the study. The radiographs are standard of care for various hand and wrist conditions and patients will be sent for radiographs only as part of their care. The patients will be eligible for the study following informed consent. The CT scan will be performed at 5-7 wrist positions: neutral, maximum extension, flexion, radial deviation, ulnar deviation (plus radial extension and ulnar flexion for 7 positions). Slice thickness will be less than 1 mm. The slices will be located between distal radioulnar joint (DRUJ) and the 2nd carpometacarpal (CMC) joint. The CT scans will then be sent for evaluation by the computer based kinematic program. No identifiable information will be collected or recorded. The program will develop a kinematic model of the STT joint in the presence of arthritis.
The model (kinematic data) will be compared to an existent "normal" model, based on 7 CT scans of normal STT joints. This data is already in existence and therefore no normal wrists are accrued.
- Conditions
- Wrist Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
motion in the STT joint
A kinematic model based on data from the wrist CT acquired in the different wrist positions.(kinematic data) will be compared to an existent "normal" model, based on 7 CT scans of normal STT joints.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ronit Wollstein, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510326
- Sponsor's protocol ID
- STT
- Status last verified
- Jan 2018
- First submitted
- 23 Mar 2014
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Motion in the Arthritic Wrist Joint
- ClinicalTrials.gov ID
- NCT02510326
- Acronym / sponsor ID
- STT
- Conditions
- Wrist Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Jul 2015 (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 scaphotrapeziotrapezoid (STT) joint is a dome shaped joint in the radial wrist that is important in transfer of load from the thumb and radial hand to the scaphoid and the radioscaphoid and scaphocapitate joints. Arthritis in this joint is the second most common degenerative arthritis in the wrist, reported in 15% of wrist radiographs. The true incidence of arthritis in the STT joint however is unknown though we assume that most cases of arthritis are not clinically significant. Furthermore, the clinical and biomechanical significance of arthritis in this joint is unclear. The investigators' clinical impression is that the incidence of STT joint arthritis is inversely related to that of radiocarpal joint arthritis. In an ongoing study, we are examining the relationship between STT joint arthritis and radiocarpal joint arthritis on radiographs.
We suggest that STT joint arthritis alters the biomechanics of the wrist by limiting movement of the scaphoid within the STT joint thereby protecting the wrist from radiocarpal arthritis by limiting instability of the scaphoid.
The specific aims of this pilot study are to evaluate the movement of the arthritic scaphoid within the STT joint using a computer-generated model based on CT scan of the wrist and to compare this model with the already established model of the normal STT joint.
The investigators' hypothesis is that there is significantly less motion in the arthritic STT joint.
Detailed description
Because it is poorly understood, the treatment of wrist arthritis remains limited to suboptimal salvage operations and wrist fusions. These are surgeries, which greatly limit function. This study is designed to evaluate arthritis of the STT joint and its affect on arthritis in other parts of the wrist. This may improve the understanding of wrist mechanics enabling us to develop better treatment of wrist arthritis. STT joint arthrodesis is an accepted surgery whose indications may be influenced by information obtained in this study.
Five patients being treated by the PI that have a diagnosis or a finding of STT joint arthritis stage 3 on X-ray will be included in the study. The radiographs are standard of care for various hand and wrist conditions and patients will be sent for radiographs only as part of their care. The patients will be eligible for the study following informed consent. The CT scan will be performed at 5-7 wrist positions: neutral, maximum extension, flexion, radial deviation, ulnar deviation (plus radial extension and ulnar flexion for 7 positions). Slice thickness will be less than 1 mm. The slices will be located between distal radioulnar joint (DRUJ) and the 2nd carpometacarpal (CMC) joint. The CT scans will then be sent for evaluation by the computer based kinematic program. No identifiable information will be collected or recorded. The program will develop a kinematic model of the STT joint in the presence of arthritis.
The model (kinematic data) will be compared to an existent "normal" model, based on 7 CT scans of normal STT joints. This data is already in existence and therefore no normal wrists are accrued.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Five patients being treated by the PI that have a diagnosis or a finding of STT joint arthritis stage 3 on X-ray will be included in the study.
Key inclusion criteria (3 listed)
- Patients with STT joint osteoarthritis(OA) - stage 3
- Exclusion Criteria: incomplete radiographs, early stage STT OA
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
motion in the STT joint
Time frame: 1 year
A kinematic model based on data from the wrist CT acquired in the different wrist positions.(kinematic data) will be compared to an existent "normal" model, based on 7 CT scans of normal STT joints.
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 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrist Osteoarthritis, run by Clalit Health Services at 1 site in Israel.
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 3 inclusion and 0 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 2018. 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 Israel. 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?
motion in the STT joint (time frame: 1 year). 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 29 Jan 2018.