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Thumb OsteoarthritisNCT04828954

Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb

A study testing Immobilization for 2-weeks postoperative and Immobilization for 6-weeks postoperative in people with Thumb Osteoarthritis, run by University of Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Thumb carpometacarpal (CMC) osteoarthritis (OA) is common, seen frequently in middle-aged and elderly women. While a variety of surgical treatments have been described with none superior to any other, there is no consensus on the optimal duration of postoperative immobilization. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Thumb Osteoarthritis
What is being tested?
Immobilization for 2-weeks postoperative and Immobilization for 6-weeks postoperative
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
19 Apr 2021to 4 Aug 2027
Phase
Interventional
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >= 40 years old
  • Patients undergoing arthroplasty of the first CMC joint including:
  • Trapeziectomy with LRTI
  • Simple Trapeziectomy
  • Suspensionplasty (suture vs. APL)

Who cannot join

  • Patients < 40 years of age
  • Patients who have undergone prior surgical procedures on the thumb base
  • Patients with history of prior procedure at the base of thumb, or those with plan for concomitant carpal tunnel release or thumb metacarpophalangeal (MCP) arthrodesis, will be excluded. Concomitant carpal tunnel surgery may skew outcome surveys, and an arthrodesis procedure will warrant a longer length of immobilization following procedure.
  • Those undergoing implant arthroplasty
  • Patients with a diagnosis of inflammatory arthritis
  • Patients with diagnosis of hypermobility syndrome

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Justin Bell contact

jbell3@bsd.uchicago.edu

United States1 site, 1 recruiting
  • University of Chicago Medicine

    Chicago, Illinois, 60637

    Andrew Straszewski, MD, Andrew.Straszewski@uchospitals.edu

    Jennifer Wolf, MD, jwolf@bsd.uchicago.edu

    Recruiting

Other trials in United States

About this study

Thumb carpometacarpal (CMC) osteoarthritis (OA) is common, seen frequently in middle-aged and elderly women. While a variety of surgical treatments have been described with none superior to any other, there is no consensus on the optimal duration of postoperative immobilization. Immobilization following surgery is critical for wound healing, pain control, and aid with activities of daily living in the early recovery period, though the duration of this must be weighed against the negative impacts of immobilization, such as stiffness, contracture, and delay in return to full function. The information gained in this study may allow hand surgeons to use an evidence-based postoperative rehabilitation protocol. Thus, our goal is to compare varying durations of postoperative immobilization after thumb CMC arthroplasty in a randomized trial design.

Subjects will be randomized to treatment with non-removable thumb spica plaster postoperative splint immobilization for 2 weeks or non-removable thumb spica plaster splint transitioned to cast for a total of 6 weeks immobilization following base of thumb arthroplasty. Patient-reported outcome measures (PROs) and objective metrics will be tracked in the follow-up period.

Read the detailed description

Thumb CMC OA is common, with radiographic prevalence ranging from 7% to 35% in the literature, with symptomatic OA affecting 2% to 6% of the population. There is predilection for involvement of the non-dominant hand, and thumb CMC OA is the leading cause of hand pain due to degenerative changes. Gender-specific differences in thumb CMC OA prevalence have also been described in the literature. Retrospective review of 615 patients revealed a 6-fold higher prevalence of thumb basilar joint OA for females in nearly every age group, noting the presence of radiographic OA at younger ages in females, and quicker progression to end-stage degenerative changes.

While conservative treatment, such as injections, therapy, splinting, and pharmacotherapy, may palliate symptoms, operative intervention is recommended if symptoms are persistent. Trapeziectomy with or without suspensionplasty is most commonly performed for advanced osteoarthritis, and studies have shown that trapeziectomy with ligament reconstruction and tendon interposition (LRTI) is the most frequently performed procedure. Because of the extensive nature of this surgery with dissection and removal of the trapezium as a common central procedure, immobilization of the thumb and wrist has been a standard part of postoperative protocols to improve postoperative pain, function, and aid with return to daily activities.

Across many studies of operative technique and post-surgical care, there is no high-level evidence on the optimal duration of postoperative immobilization. With no consensus on the duration during which patients should restrict range of motion after thumb CMC joint surgery, there is a gap in knowledge on this topic. Immobilization following surgery is critical for wound healing, pain control, and aid with activities of daily living in the early recovery period, though the duration of this must be weighed against the negative impacts of immobilization, such as stiffness, contracture, and delay in return to full function. The information gained in this study may allow hand surgeons to use an evidence-based postoperative rehabilitation protocol. Thus, our goal is to compare varying durations of postoperative immobilization after thumb CMC arthroplasty in a randomized trial design.

In this study, we will prospectively evaluate varied duration of postoperative immobilization in patients older than 40 years, undergoing base of thumb arthroplasty at an academic, tertiary referral center. Patients will be randomized to either 2 or 6 weeks of immediate postoperative immobilization in a plaster thumb spica splint or cast. Functional outcome measures, including quickDASH (Disabilities of Arm, Shoulder, and Hand), PROMIS UE (Patient Reported Outcome Measures Information System Upper Extremity) form, and VAS (Visual Analog Scale) pain scale will be captured at short-term, intermediate-term, and final follow-up periods. Additionally, exploratory objective metrics, such as strength, range of motion (ROM), return to work, and occupational therapy (OT) utilization will be monitored at all time periods.

Randomization into two cohorts of postoperative rehabilitation will occur via sealed envelope at the time of surgery. Patients will be consented through a formal written process detailing the purpose, risks, and benefits. Randomization will occur in a 1:1 ratio into 2-week versus 6-week immobilization groups. Opaque envelopes will be sealed and only opened at the time of randomization, immediately after completion of the surgical procedure, in the post-anesthesia care unit (PACU). Every patient will be immobilized postoperatively in a nonremovable thumb spica plaster splint to allow for swelling. At the 2 week (+/- 3 days) postoperative visit, patients will be placed into either a cast for 4 additional weeks of immobilization (6-week immobilization group) or be provided a removable thermoplastic thumb spica splint (2-week immobilization group) and specifically instructed to use it for comfort "as needed" with removal at their discretion. A similarly fashioned thermoplastic thumb spica splint will be provided to the 6-week group after the duration of their immobilization, again with instructions for "as needed" use. At the conclusion of each group's respective immobilization period, the same standardized hand therapy rehabilitation regimen will be initiated.

Being tested
Immobilization for 2-weeks postoperative, Immobilization for 6-weeks postoperative
Keywords
Thumb carpometacarpal joint osteoarthritis, Rehabilitation, Hand therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immobilization for 2-weeks postoperativeOther

    Non-removable thumb spica plaster postoperative splint immobilization worn for 2 weeks

  • Immobilization for 6-weeks postoperativeOther

    Non-removable postoperative thumb spica splint immobilization worn for 2 weeks (+/- 3 days), to be transitioned to thumb spica cast for an additional 4 weeks (Total of 6 weeks immobilization)

Study groups in NCT04828954
Study groupRoleWhat they receive
2 weeks of immobilizationActive comparatorSubjects randomized to this arm will be rigidly immobilized in a plaster postoperative thumb spica splint for 2 weeks following their thumb CMC arthroplasty
Receives: Other: Immobilization for 2-weeks postoperative
6 weeks of immobilizationActive comparatorSubjects randomized to this arm will be rigidly immobilized in a plaster postoperative thumb spica splint, transitioned to cast, for a total of 6 weeks following their thumb CMC arthroplasty
Receives: Other: Immobilization for 6-weeks postoperative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quick Disabilities of Arm, Shoulder, and Hand (quickDASH) Questionnaire scores

    The 11 question disability survey will be scored if at least 10 of the items are completed. The average score of responses (maximum of 5) will be obtained and transformed into score of 0 to 100 by subtracting one and multiplying by 25. A higher score indicated greater disability. The scores between treatment arms will be compared, as well as comparison of baseline scores with subsequent follow-up scores within each treatment arm. Administered at baseline visit, and 2-week, 6-week, 3-month and 1-year post-operative follow up visits.

    Measured: Change from baseline quickDASH to 3-months

Secondary outcomes (2)
  1. Visual Analog Scale (VAS) Pain scale

    Visual analog pain scale where scores of "0" indicate no pain and scores of "10" indicate maximum pain. The scores between treatment arms will be compared, as well as comparison of baseline scores with subsequent follow-up scores within each treatment arm. Administered at baseline visit, and 2-week, 6-week, 3-month and 1-year post-operative follow up visits.

    Measured: Change from baseline VAS to 3-months

  2. Patient-Reported Outcome Measures Information System (PROMIS) Upper Extremity scores

    PROMIS Upper Extremity scores will be obtained via IPAD at baseline, 2-week, 6-week, 3-month, and 1-year follow-up appointments. The PROMIS domains are obtained via computer adaptive testing (CAT) with a mean of 50 and standard deviation of 10 for reference populations. A higher score indicates greater function. The scores between treatment arms will be compared, as well as comparison of baseline scores with subsequent follow-up scores within each treatment arm. Administered at baseline visit, and 2-week, 6-week, 3-month and 1-year post-operative follow up visits.

    Measured: Change from baseline PROMIS to 3-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2021
  2. Study start19 Apr 2021
  3. Primary completion4 May 2027 (estimated)
  4. Study completion4 Aug 2027 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04828954
Sponsor's protocol ID
IRB20-1651
Status last verified
May 2026
First submitted
26 Mar 2021
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Do not plan to share individual participant data with other researchers

Questions about this trial

What is this clinical trial studying?

A study testing Immobilization for 2-weeks postoperative and Immobilization for 6-weeks postoperative in people with Thumb Osteoarthritis, run by University of Chicago 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 6 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 13 May 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 Andrew Straszewski, MD (773-834-3531, Andrew.Straszewski@uchospitals.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quick Disabilities of Arm, Shoulder, and Hand (quickDASH) Questionnaire scores (time frame: Change from baseline quickDASH to 3-months). 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 13 May 2026.

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