Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb
ConditionThumb Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 40 years old
Trapeziectomy with LRTI
Simple Trapeziectomy
Suspensionplasty (suture vs. APL)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Immobilization for 2-weeks postoperative
Other interventionNon-removable thumb spica plaster postoperative splint immobilization worn for 2 weeks
Immobilization for 6-weeks postoperative
Other interventionNon-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)
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: 2 weeks of immobilizationActive comparator 1 intervention
Group B: 6 weeks of immobilizationActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Change from baseline quickDASH to 3-monthsSecondary outcomes
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.
Time frame
Change from baseline VAS to 3-months2
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.
Time frame
Change from baseline PROMIS to 3-monthsSponsors and contacts
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Source ClinicalTrials.gov