CMC ArthritisNCT05835830
Thumb Metacarpophalangeal Hyperextension in an Arthritic Population; Part 2
An observational study of CMC Arthritis, run by Indiana Hand to Shoulder Center at 1 site in United States.
Trial summary
This is the second phase of a clinical study to assess MP hyperextension in CMC arthritis. In the first phase, submitted for publication, the investigators demonstrated that there is poor correlation between dynamic control of the MP joint and the amount of passive hyperextension preoperatively in a sample of patients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CMC Arthritis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2020to Dec 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients presenting in clinic with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis will be screened for participation in study.
Who may be able to join
- • Adults (18 years of age or older)
- Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis
- Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays
- Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study
- Patients with greater than 20 degrees of passive MP Hyperextension
- o Screened by surgeons upon first evaluation in clinic
- Bilateral thumbs included
Who cannot join
- • <18 years age
- Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb MP or CMC joints
- Prior ipsilateral 1st ray deformity or malunion, distal radial malunion or nonunion, 2nd ray amputation or deformity
- Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy
- Inflammatory arthritis
- Post-traumatic CMC arthritis
Show all 9Show fewer
- Prior trauma to the MP or CMC joints
- Diagnosis of Ehler-Danlos syndrome or other connective tissue disorder
- Concomitant treatment of the MP joint
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
About this study
This is the second phase of a clinical study to assess MP hyperextension in CMC arthritis. In the first phase, submitted for publication, the investigators demonstrated that there is poor correlation between dynamic control of the MP joint and the amount of passive hyperextension preoperatively in a sample of patients with CMC arthritis.
Read the detailed description
To date, no studies have looked at the relationship of preoperative and postoperative MP pinch position and passive MP hyperextension in an arthritic patient population. Other research has found that dynamic thumb MP pinch position is independent of passive MP hyperextension in a healthy non-arthritic population (thumbs with passive MP hyperextension on exam did not pinch in a position of MP hyperextension), but no such investigation has been performed in an arthritic population pre and postoperatively. It is also undetermined which of these parameters (dynamic pinch or passive MP hyperextension) has a larger correlation to postoperative outcomes following basilar joint arthroplasty, and which parameter should be considered when determining whether or not to surgically stabilize the MP joint at the time of CMC arthroplasty.
The specific aim of this study is to compare the preoperative and postoperative changes in dynamic and passive range of motion of the thumb MP joint in patients undergoing CMC basilar joint reconstruction without concomitant MP joint stabilization.
Secondary aims of this study will be to compare postoperative pinch and grasp strength, radiographic subsidence and longitudinal collapse, in addition to postoperative patient reported outcomes in patients with good dynamic MP control (<5 degrees) vs poor dynamic control (>5degrees)
The hypothesis is that dynamic thumb MP pinch position will not change compared with its preoperative status. Investigators also hypothesize that patients with better dynamic pinch position postoperatively will have better pinch strength and better functional outcomes than patients with poor dynamic pinch position.
- Conditions
- CMC Arthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive Thumb MP Hyperextension
degree of MP Hyperextension measured in clinic
Measured: 12 months
Dynamic thumb MP Hyperextension (key pinch)
lateral key pinch measured with pinch gauge
Measured: 12 months
Dynamic thumb MP position during cylindrical grasp
range of motion measure of thumb MP joint around a cylindrical object (peanut butter jar and water bottle)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start6 Oct 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMC ArthritisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana Hand to Shoulder Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835830
- Sponsor's protocol ID
- MP Hyperextension
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thumb Metacarpophalangeal Hyperextension in an Arthritic Population; Part 2
- ClinicalTrials.gov ID
- NCT05835830
- Acronym / sponsor ID
- MP Hyperextension
- Conditions
- CMC Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Indiana Hand to Shoulder CenterUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Apr 2023 (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 is the second phase of a clinical study to assess MP hyperextension in CMC arthritis. In the first phase, submitted for publication, the investigators demonstrated that there is poor correlation between dynamic control of the MP joint and the amount of passive hyperextension preoperatively in a sample of patients with CMC arthritis.
Detailed description
To date, no studies have looked at the relationship of preoperative and postoperative MP pinch position and passive MP hyperextension in an arthritic patient population. Other research has found that dynamic thumb MP pinch position is independent of passive MP hyperextension in a healthy non-arthritic population (thumbs with passive MP hyperextension on exam did not pinch in a position of MP hyperextension), but no such investigation has been performed in an arthritic population pre and postoperatively. It is also undetermined which of these parameters (dynamic pinch or passive MP hyperextension) has a larger correlation to postoperative outcomes following basilar joint arthroplasty, and which parameter should be considered when determining whether or not to surgically stabilize the MP joint at the time of CMC arthroplasty.
The specific aim of this study is to compare the preoperative and postoperative changes in dynamic and passive range of motion of the thumb MP joint in patients undergoing CMC basilar joint reconstruction without concomitant MP joint stabilization.
Secondary aims of this study will be to compare postoperative pinch and grasp strength, radiographic subsidence and longitudinal collapse, in addition to postoperative patient reported outcomes in patients with good dynamic MP control (<5 degrees) vs poor dynamic control (>5degrees)
The hypothesis is that dynamic thumb MP pinch position will not change compared with its preoperative status. Investigators also hypothesize that patients with better dynamic pinch position postoperatively will have better pinch strength and better functional outcomes than patients with poor dynamic pinch position.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presenting in clinic with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis will be screened for participation in study.
Key inclusion criteria (7 listed)
- • Adults (18 years of age or older)
- o Screened by surgeons upon first evaluation in clinic
Key exclusion criteria (9 listed)
- • <18 years age
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
Passive Thumb MP Hyperextension
Time frame: 12 months
degree of MP Hyperextension measured in clinic
Dynamic thumb MP Hyperextension (key pinch)
Time frame: 12 months
lateral key pinch measured with pinch gauge
Dynamic thumb MP position during cylindrical grasp
Time frame: 12 months
range of motion measure of thumb MP joint around a cylindrical object (peanut butter jar and water bottle)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
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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 CMC Arthritis, run by Indiana Hand to Shoulder Center at 1 site in United States.
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 7 inclusion and 9 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 1 May 2023. 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 United States. 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?
Passive Thumb MP Hyperextension (time frame: 12 months). The study lists 3 primary outcomes in all. 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 May 2023.