Immobilization Duration for Thumb Osteoarthritis

Overseen By Andrew Straszewski, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Prior thumb surgery, Inflammatory arthritis, Hypermobility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2-6 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal duration for thumb immobilization after surgery for thumb osteoarthritis, a common joint condition causing pain and stiffness. It will compare two groups: one wearing a thumb splint for 2 weeks and another for 6 weeks post-surgery. The study seeks participants aged 40 and older with thumb osteoarthritis who plan to undergo specific types of thumb joint surgery, such as arthroplasty of the carpometacarpal joint. The goal is to identify the most effective recovery plan to balance healing with returning to daily activities. As an unphased trial, it offers participants the chance to contribute to optimizing post-surgery recovery plans for future patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this immobilization protocol is safe for postoperative recovery?

Research has shown that a shorter immobilization period, such as 2 weeks, is safe. Studies indicate that shorter durations can prevent discomfort and are often just as effective for healing and recovery. For the 6-week immobilization, research suggests that longer periods do not provide additional benefits compared to shorter ones. Both lengths of immobilization have been used before and are generally well-tolerated by patients. No significant reports of serious side effects have emerged from either duration, making both options relatively low-risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it could redefine recovery times for thumb osteoarthritis surgery. Most current treatments involve long immobilization periods, often lasting several weeks, to ensure proper healing after thumb joint surgery. However, this trial is testing whether a shorter immobilization period of just two weeks could be as effective as the traditional six weeks. If successful, this approach could lead to faster recovery times, allowing patients to return to their daily activities sooner. This trial is especially promising as it could offer a more convenient and less restrictive recovery option for those undergoing thumb surgery.

What evidence suggests that this trial's immobilization durations could be effective for thumb osteoarthritis?

This trial will compare two durations of immobilization following thumb CMC arthroplasty: 2 weeks and 6 weeks. Research has shown that immobilizing the thumb for a shorter period, such as 2 weeks, after thumb CMC surgery is safe and recommended. Studies indicate that immobilizing it for more than 6 weeks does not provide additional benefits. Shorter immobilization helps prevent discomfort and stiffness while still supporting healing. In contrast, immobilizing for 6 weeks has not shown better results than shorter periods. This trial studies both time frames to find the best balance between healing and avoiding issues like stiffness. ^{1 3 4 6 7}

Who Is on the Research Team?

Jennifer Wolf, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for individuals over 40 years old who are having surgery for thumb osteoarthritis but haven't had previous surgeries on the thumb base. It's not suitable for those with inflammatory arthritis, hypermobility syndrome, or anyone needing additional procedures like carpal tunnel release.

Inclusion Criteria

I am 40 years old or older.

I am having surgery on my thumb joint.

Exclusion Criteria

I have had surgery on the base of my thumb before.

I have not had surgery at the base of my thumb or plan to have surgery for carpal tunnel or thumb joint fusion.

I have been diagnosed with inflammatory arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo thumb CMC arthroplasty followed by randomized immobilization in a plaster thumb spica splint for either 2 or 6 weeks

2-6 weeks

1 visit (in-person) for surgery and initial immobilization

Rehabilitation

Standardized hand therapy rehabilitation regimen initiated after immobilization period

4 weeks

Weekly visits (in-person) for hand therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2-week, 6-week, 3-month, and 1-year post-operative follow-up visits

1 year

Multiple visits (in-person) at specified intervals

What Are the Treatments Tested in This Trial?

Interventions

• Arthroplasty of the Carpometacarpal Joint of the Thumb
• Immobilization

Trial Overview The study tests two different lengths of time that a patient's thumb is kept immobile after surgery: one group will have their thumb immobilized for 2 weeks and another group for 6 weeks. The goal is to see which duration is better for recovery.

How Is the Trial Designed?

Group I: 2 weeks of immobilization Active Control 1 Intervention

Subjects randomized to this arm will be rigidly immobilized in a plaster postoperative thumb spica splint for 2 weeks following their thumb CMC arthroplasty

Group II: 6 weeks of immobilization Active Control 1 Intervention

Subjects 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

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

In a study comparing 75 trapeziectomies and 110 ARPE thumb CMCJ arthroplasties, the ARPE arthroplasty showed significantly better post-operative function and higher patient satisfaction scores, indicating it may be a more effective option for treating thumb osteoarthritis.

Despite its advantages, the ARPE arthroplasty had a higher complication rate, with 14% of patients needing further surgery, highlighting the importance of careful patient selection and counseling before the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Results of the ARPE Arthroplasty Versus Trapeziectomy for the Treatment of Thumb Carpometacarpal Joint Osteoarthritis. Craik, JD., Glasgow, S., Andren, J., et al.[2019]

In a study of 60 patients with thumb carpometacarpal joint osteoarthritis, treatment involving denervation, joint lavage, and capsular imbrication led to significant pain reduction and improved thumb function over a follow-up period averaging 46 months.

This treatment approach is a promising alternative to more invasive surgeries, offering benefits such as low complication rates, minimal invasiveness, and shorter recovery times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of denervation, joint lavage and capsular imbrication for painful thumb carpometacarpal joint osteoarthritis. Ehrl, D., Erne, HC., Broer, PN., et al.[2022]

A modified suspension arthroplasty technique for treating primary osteoarthritis of the thumb carpometacarpal joint was performed on 41 patients, resulting in high subjective satisfaction for 40 of them and excellent outcomes in 45 operations.

This technique minimized the need for extensive tendon preparation, allowing for only 3 weeks of immobilization post-surgery, which contributed to good early functional results and reduced patient morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Suspension arthroplasty of the thumb carpometacarpal joint: modified surgical technique, follow-up treatment and results--a retrospective analysis of 51 operations]. Brand, J., Gaulke, R., Geerling, J., et al.[2018]

In a study of 11 patients who underwent thumb CMC hemiarthroplasty with the BioPro prosthesis, there was a significant reduction in pain from a median score of 8/10 preoperatively to 1/10 postoperatively, indicating high efficacy of the procedure.

The BioPro prosthesis allows for minimal bone resection and has a low risk of complications, with most patients reporting satisfaction and willingness to recommend the surgery, although one case required revision due to improper implant placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BioPro Thumb Carpometacarpal Hemiarthroplasty: Case Series and Surgical Technique. Chung, J., Albino-Hakim, S., Samuels, K., et al.[2023]

In a study of 133 patients who underwent trapeziometacarpal total joint arthroplasty for thumb osteoarthritis, 86% returned to work within 12 months, with an average time to sustainable return to work of 14 weeks.

Higher occupational hand force requirements were linked to slower return to work, with patients in medium- and high-force jobs returning at significantly lower rates compared to those in lower-force jobs, although these requirements did not affect pain or disability levels after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Occupational Hand Force Requirements on Return to Work, Pain, and Disability After Trapeziometacarpal Total Joint Arthroplasty: A 12-Month Follow-Up Study. Kirkeby, L., Frost, P., Hansen, TB., et al.[2021]

In a review of 48 surgeries for thumb carpometacarpal joint arthrodesis in 39 patients, 58% experienced excellent pain relief, and hand function was nearly normal, with comparable grip strength to the unoperated hand.

However, the procedure had a high rate of complications, including a 29% need for additional surgeries to remove hardware and a 29% non-union rate, leading to a recommendation for soft tissue procedures instead of arthrodesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of arthrodesis of the carpometacarpal joint of the thumb. Damen, A., Dijkstra, T., van der Lei, B., et al.[2019]

In a study of 170 patients with thumb carpometacarpal osteoarthritis, nonsurgical treatments (exercise therapy and orthosis) showed no significant worsening of pain or limitations in daily activities over more than 5 years, indicating sustained benefits after initial treatment.

The rate of conversion to surgery was 22% at a median follow-up of 7 years, suggesting that while some patients may eventually require surgery, nonsurgical treatment remains a viable first-line option for managing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Nonsurgical Treatment of Thumb Carpometacarpal Osteoarthritis: A Cohort Study. Esteban Lopez, LMJ., Hoogendam, L., Vermeulen, GM., et al.[2023]

The ARPE arthroplasty procedure for thumb osteoarthritis showed excellent short-term results in pain relief, mobility, and strength among 63 patients followed for at least six months, with high patient satisfaction reported.

While the procedure is effective and requires no rehabilitation, the most common complications were implant luxation and loosening, which can be addressed with simple surgical solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Short term results of total carpometacarpal joint replacement surgery using the ARPE implant for primary ostearthritis of the thumb]. Brutus, JP., Kinnen, L.[2019]

In a study involving 63 hands with early-stage thumb carpometacarpal osteoarthritis, the use of a prefabricated immobilization splint for 6 weeks significantly reduced pain and improved hand function compared to a nonsplint group.

Patients using the splint also showed notable increases in grip and pinch strength, indicating that the splint not only alleviates symptoms but also enhances physical capabilities in affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of hand splinting in patients with early-stage thumb carpometacarpal joint osteoarthritis: a randomized, controlled study Can, A., Tezel, N.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31026460/

Shorter vs Longer Immobilization After Surgery for Thumb ... These results indicate that shorter immobilization is safe and can be recommended, since discomfort of longer immobilization may be prevented and patients may ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9492801/

Immobilization and Hand Therapy After Carpometacarpal ... Longer immobilization times (>6 weeks) and rigid orthotic devices provide no additional benefit over earlier immobilization and semirigid orthotic devices.

3. trials.arthritis.org trials.arthritis.org/trials/NCT04828954

Variable Immobilization Protocol for Arthroplasty of the ... Patients will be randomized to either 2 or 6 weeks of immediate postoperative immobilization in a plaster thumb spica splint or cast. Functional outcome ...

4. withpower.com withpower.com/trial/immobilization-duration-for-thumb-osteoarthritis-d6f23

Immobilization Duration for Thumb Osteoarthritis The ARPE arthroplasty procedure for thumb osteoarthritis showed excellent short-term results in pain relief, mobility, and strength among 63 patients followed ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2468122924002147

Immobilization, rehabilitation and complications ... The best way of immobilization as well as effectiveness of rehabilitation for trapeziometacarpal total joint arthroplasty is unknown.

6. jhsgo.org jhsgo.org/article/S2589-5141(22)00069-X/fulltext

Immobilization and Hand Therapy After Carpometacarpal ... Longer immobilization times (>6 weeks) and rigid orthotic devices provide no additional benefit over earlier immobilization and semirigid orthotic devices.

7. archives-pmr.org archives-pmr.org/article/S0003-9993(19)30259-X/abstract

Shorter vs Longer Immobilization After Surgery for Thumb ... In conclusion, shorter immobilization of 3-5 days of a plaster cast after Weilby procedure is equal to longer immobilization for outcomes on ...