Osteoarthritis ThumbRESTARTNCT04458584
Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)
An observational study of Osteoarthritis Thumb, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the basis for three widely held fundamental tenets about surgical intervention for thumb basal joint arthritis; 1. Trapeziectomy with ligament reconstruction and metacarpal stabilization is associated with superior functional outcomes and strength, 2. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis Thumb
- What is being tested?
- Trapeziectomy with ligament reconstruction (I; LRTI), Trapeziectomy with suture suspensionplasty (II; SS) and Arthroscopic Trapeziectomy (III; AT)
- Type of treatment
- Surgery or procedure
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Adult, Older adult
Study population: All consecutive patients seen at participating centers who have failed non-operative treatment and are considering primary basal joint arthroplasty for a diagnosis of thumb basal joint osteoarthritis, post-traumatic arthritis, or have undergone a prior basal joint procedure for either fracture or instability resulting in persistent synovitis and are bothered by persistent symptoms, will be considered for participation in the study.
Who may be able to join
- Males and females 21 years of age or older;
- Undergoing elective non-prosthetic, primary basal joint arthroplasty;
- Patient has necessary mental capacity to participate and comply with study protocol;
- Patient is willing and able to give informed consent; and
- Patient is willing to participate under the care of their chosen surgeon.
Who cannot join
- Patients with a diagnosis of rheumatoid arthritis, systemic lupus erythematosis, psoriatic arthritis, or other related inflammatory arthritis;
- Patients undergoing simultaneous bilateral hand procedures of any nature;
- Women who are pregnant or breastfeeding;
- Women of reproductive potential unless there is a negative urine pregnancy test on the day of surgery. Women of child bearing potential include those who are premenopausal who have not had a bilateral oophorectomy, hysterectomy or tubal ligation. Post-menopausal is defined as not having had a menstrual period for at least one calendar year.
- Vulnerable patient populations including prisoners and institutionalized individuals.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Vincent D Pellegrini, MD, (603) 650-5133, Vincent.D.Pellegrini.Jr@hitchcock.org
Lance G Warhold, MD, (603) 650-5133, Lance.G.Warhold@hitchcock.org
About this study
The purpose of this study is to evaluate the basis for three widely held fundamental tenets about surgical intervention for thumb basal joint arthritis;
- Trapeziectomy with ligament reconstruction and metacarpal stabilization is associated with superior functional outcomes and strength,
- Preservation of the arthroplasty space correlates with functional outcomes, pain relief, and restoration of strength after basal joint arthroplasty, and
- Mitigation of metacarpophalangeal joint (MCPJ) hyperextension optimizes postoperative strength after basal joint arthroplasty, regardless of surgical technique.
Read more
It is hypothesized that thumb basal joint arthroplasty with metacarpal stabilization, by either ligament reconstruction (I) or suture suspension (II), provides greater improvement in grip and pinch strength, and better hand function, than might be achieved following provision of pain relief alone by simple trapeziectomy (III). Preservation of the arthroplasty space will correlate positively, and MCPJ hyperextension will correlate negatively, with improved thumb function and lateral pinch strength.
Primary Aims (within 3 procedure cohorts):
- Compare pre-operative pinch and grip strength as well as patient-reported outcomes (PROs) for pain in patients before and after lidocaine injection of the trapeziometacarpal joint, prior to thumb basal joint arthroplasty;
- Compare post-operative pinch and grip strength and PROs for pain and function at 3 and 6 months after thumb basal joint arthroplasty with pre-operative values before and after lidocaine injection;
- Correlate preservation of dynamic arthroplasty space as measured on a stress radiograph with postoperative improvement in pinch and grip strength, and PROs for pain and function;
- Correlate dynamic MCP joint position and laxity with change in strength and patient-reported pain and function to define optimal MCPJ position.
Secondary Aims (between 3 procedure cohorts):
- Compare change in pre- and post-operative pinch and grip strength and PROs for pain and function between patients having basal joint arthroplasty with and without specific metacarpal stabilization;
- Compare preservation of the dynamic arthroplasty space and improvement in strength and patient-reported pain and function between arthroplasty groups; and
- Compare changes in pinch and grip strength and PROs for pain and function with dynamic MCPJ position between arthroplasty groups.
- Compare postoperative neuritis and complications between surgical groups.
Read the detailed description
Study Procedures: Upon obtaining informed consent and within 4 weeks of the planned date of surgery, each site coordinator will collect baseline clinical and demographic information, a visual analogue score (VAS), the Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Survey, the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire and grip and then pinch measurements from the participant. On the same day, and immediately following collection of baseline clinical data in the clinic, the surgeon will anesthetize the trapeziometacarpal joint. Adequacy of the injection and resulting anesthesia of the joint will be assessed by repeat of the VAS score. Following 15 minutes set time for the local anesthetic, the VAS diagram will again be completed by the patient followed by recording of repeat grip and then pinch measurements. Each patient will then undergo one of three pre-specified procedures; trapeziectomy with ligament reconstruction-tendon interposition (LRTI) arthroplasty with flexor carpi radialis tendon; trapeziectomy with suture suspensionplasty; or arthroscopic trapeziectomy with temporary K-wire fixation. Patient follow-up visits are otherwise scheduled according to the surgeon's routine and by clinical indication only. The patient will follow the routine postoperative rehabilitation protocol and hand therapy program of the operating surgeon. Protective splinting and exercise programs are to be utilized per surgeon protocol and preference.Postoperative study assessment will occur at three and six months after operation, The 3 and 6 month evaluation will include PROMIS-10 and QuickDASH surveys, completion of the VAS pain diagram, and recording of grip, key, and pulp to pulp pinch strengths. Additionally, specific notation of paresthesias, dysaesthesias, or sensitivity of the incision will be made by the surgeon or hand therapist at the 3 and 6 month assessments.
- Conditions
- Osteoarthritis Thumb
- Being tested
- Trapeziectomy with ligament reconstruction (I; LRTI), Trapeziectomy with suture suspensionplasty (II; SS), Arthroscopic Trapeziectomy (III; AT)
- Keywords
- Ligament reconstruction, Suspensionplasty, Arthroscopic Trapeziectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trapeziectomy with ligament reconstruction (I; LRTI)Procedure or surgery
Also called NOTE: NO devices or drugs are included as part of this intervention.
Thumb basal joint arthroplasty (surgical) using Trapeziectomy with ligament reconstruction (I; LRTI)
Trapeziectomy with suture suspensionplasty (II; SS)Procedure or surgery
Also called NOTE: NO devices or drugs are included as part of this intervention.
Thumb basal joint arthroplasty (surgical) using Trapeziectomy with suture suspension-lastly (II; SS)
Arthroscopic Trapeziectomy (III; AT)Procedure or surgery
Also called NOTE: NO devices or drugs are included as part of this intervention.
Thumb basal joint arthroplasty (surgical) using Arthroscopic Trapeziectomy (III; AT)
| Study group | Role | What they receive |
|---|---|---|
| Ligament Reconstruction - Tendon Interposition (LRTI) | Patients undergoing thumb basal joint arthroplasty using LRTI procedure as treatment of osteoarthritis. Receives: Procedure: Trapeziectomy with ligament reconstruction (I; LRTI) | |
| Suture Suspensionplasty (SS) | Patients undergoing thumb basal joint arthroplasty using suture suspensionplasty (SS) procedure as treatment of osteoarthritis. Receives: Procedure: Trapeziectomy with suture suspensionplasty (II; SS) | |
| Arthroscopic Trapeziectomy (AT) | Patients undergoing thumb basal joint arthroplasty using arthroscopic trapeziectomy (AT) procedure as treatment of osteoarthritis. Receives: Procedure: Arthroscopic Trapeziectomy (III; AT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pre-operative pinch and grip strength as measured by kilograms of pressure within and between procedure cohorts before and after lidocaine injection of the trapeziometacarpal joint.
Power grip using a Jamar (Jackson, MO) dynamometer, followed by lateral (key) and pulp-to-pulp pinch, will be recorded (in kilograms) with a pinch meter, taking the greater strength of three successive attempts at each position with a 15 second rest between each attempt. The dynamic position of the thumb metacarpophalangeal (MCP) joint will be recorded with a small goniometer during lateral pinch testing.
Measured: Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery
Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain within and between procedure cohorts.
The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face).
Measured: Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery
Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, within and between procedure cohorts.
The short form QuickDASH questionnaire will be completed as a reflection of patient-reported specific upper extremity function. Absolute improvement in QuickDASH score will be compared within groups longitudinally and between groups at each time point. QuickDASH scores range from 0 (no disability) to 100 (most severe disability).
Measured: Baseline, 3 months and 6 months after surgery
Change in Quality of Life as measured by the PROMIS-10 Global Health questionnaire, within and between procedure cohorts.
The PROMIS-10 Global Health measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. A higher score indicates better health.
Measured: Baseline, 3 months and 6 months after surgery
Secondary outcomes (3)
Postoperative complications between procedure cohorts
Postoperative complications specifically related to superficial sensory neuritis or complex regional pain syndrome and wound related infection, between arthroplasty groups.
Measured: 3 months and 6 months post surgery
Change in absolute dynamic arthroplasty space height as measured by on a stress radiograph within and between procedure and cohorts
The static and dynamic arthroplasty space will be comparatively assessed on immediate postop and sequential radiographs taken upon removal of plaster immobilization and K-wire fixation at 1 month, and at 3 and 6 months after surgery. Three and six month radiographs will be taken in Roberts anteroposterior (AP) and true lateral projections during lateral key pinch. The absolute arthroplasty space height, and its change over time following operation and plaster removal, will be correlated with improvement in strength.
Measured: Baseline, immediately after surgery, 1 month after surgery, 3 months and 6 months after surgery
Change in dynamic metacarpophalangeal joint position (MCPJ) and laxity as measured by hand goniometer within and between procedure cohorts
Dynamic position of the MCPJ will be measured with a hand goniometer during lateral pinch testing
Measured: Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start29 Jun 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ThumbStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent D. Pellegrini, Dartmouth-Hitchcock Medical Center
- Investigators
- Vincent D Pellegrini, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458584
- Sponsor's protocol ID
- D20092
- Acronym
- RESTART
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2020
- Last updated
- 30 Jul 2026
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)
- ClinicalTrials.gov ID
- NCT04458584
- Acronym / sponsor ID
- RESTART / D20092
- Conditions
- Osteoarthritis Thumb
- Keywords
- Ligament reconstruction, Suspensionplasty, Arthroscopic Trapeziectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Jul 2020 (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.
The purpose of this study is to evaluate the basis for three widely held fundamental tenets about surgical intervention for thumb basal joint arthritis;
- Trapeziectomy with ligament reconstruction and metacarpal stabilization is associated with superior functional outcomes and strength,
- Preservation of the arthroplasty space correlates with functional outcomes, pain relief, and restoration of strength after basal joint arthroplasty, and
- Mitigation of metacarpophalangeal joint (MCPJ) hyperextension optimizes postoperative strength after basal joint arthroplasty, regardless of surgical technique.
It is hypothesized that thumb basal joint arthroplasty with metacarpal stabilization, by either ligament reconstruction (I) or suture suspension (II), provides greater improvement in grip and pinch strength, and better hand function, than might be achieved following provision of pain relief alone by simple trapeziectomy (III). Preservation of the arthroplasty space will correlate positively, and MCPJ hyperextension will correlate negatively, with improved thumb function and lateral pinch strength.
Primary Aims (within 3 procedure cohorts):
- Compare pre-operative pinch and grip strength as well as patient-reported outcomes (PROs) for pain in patients before and after lidocaine injection of the trapeziometacarpal joint, prior to thumb basal joint arthroplasty;
- Compare post-operative pinch and grip strength and PROs for pain and function at 3 and 6 months after thumb basal joint arthroplasty with pre-operative values before and after lidocaine injection;
- Correlate preservation of dynamic arthroplasty space as measured on a stress radiograph with postoperative improvement in pinch and grip strength, and PROs for pain and function;
- Correlate dynamic MCP joint position and laxity with change in strength and patient-reported pain and function to define optimal MCPJ position.
Secondary Aims (between 3 procedure cohorts):
- Compare change in pre- and post-operative pinch and grip strength and PROs for pain and function between patients having basal joint arthroplasty with and without specific metacarpal stabilization;
- Compare preservation of the dynamic arthroplasty space and improvement in strength and patient-reported pain and function between arthroplasty groups; and
- Compare changes in pinch and grip strength and PROs for pain and function with dynamic MCPJ position between arthroplasty groups.
- Compare postoperative neuritis and complications between surgical groups.
Detailed description
Study Procedures: Upon obtaining informed consent and within 4 weeks of the planned date of surgery, each site coordinator will collect baseline clinical and demographic information, a visual analogue score (VAS), the Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Survey, the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire and grip and then pinch measurements from the participant. On the same day, and immediately following collection of baseline clinical data in the clinic, the surgeon will anesthetize the trapeziometacarpal joint. Adequacy of the injection and resulting anesthesia of the joint will be assessed by repeat of the VAS score. Following 15 minutes set time for the local anesthetic, the VAS diagram will again be completed by the patient followed by recording of repeat grip and then pinch measurements. Each patient will then undergo one of three pre-specified procedures; trapeziectomy with ligament reconstruction-tendon interposition (LRTI) arthroplasty with flexor carpi radialis tendon; trapeziectomy with suture suspensionplasty; or arthroscopic trapeziectomy with temporary K-wire fixation. Patient follow-up visits are otherwise scheduled according to the surgeon's routine and by clinical indication only. The patient will follow the routine postoperative rehabilitation protocol and hand therapy program of the operating surgeon. Protective splinting and exercise programs are to be utilized per surgeon protocol and preference.Postoperative study assessment will occur at three and six months after operation, The 3 and 6 month evaluation will include PROMIS-10 and QuickDASH surveys, completion of the VAS pain diagram, and recording of grip, key, and pulp to pulp pinch strengths. Additionally, specific notation of paresthesias, dysaesthesias, or sensitivity of the incision will be made by the surgeon or hand therapist at the 3 and 6 month assessments.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ligament Reconstruction - Tendon Interposition (LRTI) | – | Procedure: Trapeziectomy with ligament reconstruction (I; LRTI)Patients undergoing thumb basal joint arthroplasty using LRTI procedure as treatment of osteoarthritis. |
| Suture Suspensionplasty (SS) | – | Procedure: Trapeziectomy with suture suspensionplasty (II; SS)Patients undergoing thumb basal joint arthroplasty using suture suspensionplasty (SS) procedure as treatment of osteoarthritis. |
| Arthroscopic Trapeziectomy (AT) | – | Procedure: Arthroscopic Trapeziectomy (III; AT)Patients undergoing thumb basal joint arthroplasty using arthroscopic trapeziectomy (AT) procedure as treatment of osteoarthritis. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients seen at participating centers who have failed non-operative treatment and are considering primary basal joint arthroplasty for a diagnosis of thumb basal joint osteoarthritis, post-traumatic arthritis, or have undergone a prior basal joint procedure for either fracture or instability resulting in persistent synovitis and are bothered by persistent symptoms, will be considered for participation in the study.
Key inclusion criteria (5 listed)
- Males and females 21 years of age or older;
- Undergoing elective non-prosthetic, primary basal joint arthroplasty;
- Patient has necessary mental capacity to participate and comply with study protocol;
- Patient is willing and able to give informed consent; and
- Patient is willing to participate under the care of their chosen surgeon.
Key exclusion criteria (5 listed)
- Patients with a diagnosis of rheumatoid arthritis, systemic lupus erythematosis, psoriatic arthritis, or other related inflammatory arthritis;
- Patients undergoing simultaneous bilateral hand procedures of any nature;
- Women who are pregnant or breastfeeding;
- Women of reproductive potential unless there is a negative urine pregnancy test on the day of surgery. Women of child bearing potential include those who are premenopausal who have not had a bilateral oophorectomy, hysterectomy or tubal ligation. Post-menopausal is defined as not having had a menstrual period for at least one calendar year.
- Vulnerable patient populations including prisoners and institutionalized individuals.
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 |
|---|---|---|
| Trapeziectomy with ligament reconstruction (I; LRTI)Also: NOTE: NO devices or drugs are included as part of this intervention.Thumb basal joint arthroplasty (surgical) using Trapeziectomy with ligament reconstruction (I; LRTI) | Procedure or surgery | Ligament Reconstruction - Tendon Interposition (LRTI) |
| Trapeziectomy with suture suspensionplasty (II; SS)Also: NOTE: NO devices or drugs are included as part of this intervention.Thumb basal joint arthroplasty (surgical) using Trapeziectomy with suture suspension-lastly (II; SS) | Procedure or surgery | Suture Suspensionplasty (SS) |
| Arthroscopic Trapeziectomy (III; AT)Also: NOTE: NO devices or drugs are included as part of this intervention.Thumb basal joint arthroplasty (surgical) using Arthroscopic Trapeziectomy (III; AT) | Procedure or surgery | Arthroscopic Trapeziectomy (AT) |
Primary outcome
Change in pre-operative pinch and grip strength as measured by kilograms of pressure within and between procedure cohorts before and after lidocaine injection of the trapeziometacarpal joint.
Time frame: Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery
Power grip using a Jamar (Jackson, MO) dynamometer, followed by lateral (key) and pulp-to-pulp pinch, will be recorded (in kilograms) with a pinch meter, taking the greater strength of three successive attempts at each position with a 15 second rest between each attempt. The dynamic position of the thumb metacarpophalangeal (MCP) joint will be recorded with a small goniometer during lateral pinch testing.
Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain within and between procedure cohorts.
Time frame: Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery
The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face).
Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, within and between procedure cohorts.
Time frame: Baseline, 3 months and 6 months after surgery
The short form QuickDASH questionnaire will be completed as a reflection of patient-reported specific upper extremity function. Absolute improvement in QuickDASH score will be compared within groups longitudinally and between groups at each time point. QuickDASH scores range from 0 (no disability) to 100 (most severe disability).
Change in Quality of Life as measured by the PROMIS-10 Global Health questionnaire, within and between procedure cohorts.
Time frame: Baseline, 3 months and 6 months after surgery
The PROMIS-10 Global Health measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. A higher score indicates better health.
3 secondary outcomes
Postoperative complications between procedure cohorts
Time frame: 3 months and 6 months post surgery
Change in absolute dynamic arthroplasty space height as measured by on a stress radiograph within and between procedure and cohorts
Time frame: Baseline, immediately after surgery, 1 month after surgery, 3 months and 6 months after surgery
Change in dynamic metacarpophalangeal joint position (MCPJ) and laxity as measured by hand goniometer within and between procedure cohorts
Time frame: Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- 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.
Vincent D Pellegrini, MD principal investigator
Dartmouth-Hitchcock Medical Center
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 Osteoarthritis Thumb, run by Dartmouth-Hitchcock Medical 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent D Pellegrini, MD ((603) 650-5133, Vincent.D.Pellegrini.Jr@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pre-operative pinch and grip strength as measured by kilograms of pressure within and between procedure cohorts before and after lidocaine injection of the trapeziometacarpal joint. (time frame: Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery). The study lists 4 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 30 Jul 2026.