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

Trial Summary

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 data supports the effectiveness of the treatment for thumb osteoarthritis?

Research shows that arthroplasty (joint replacement surgery) for thumb osteoarthritis can provide excellent pain relief and maintain thumb stability and range of motion, which are important for daily activities. Additionally, studies suggest that surgical options like arthroplasty may offer better long-term outcomes compared to nonsurgical treatments. ^{1 2 3 4 5}

Is immobilization for thumb osteoarthritis generally safe?

The studies reviewed suggest that surgical treatments for thumb osteoarthritis, such as hemiarthroplasty and denervation, have low complication rates and are generally safe, with good pain relief and patient satisfaction reported. However, there can be risks like implant misplacement or fractures, which may require further surgery. ^{1 2 6 7 8}

How does the treatment of arthroplasty for thumb osteoarthritis differ from other treatments?

Arthroplasty of the carpometacarpal joint of the thumb is unique because it involves replacing the joint with a prosthesis, which can preserve range of motion and provide stability without shortening the thumb. This surgical option allows for minimal bone removal, sparing the trapezium bone, and offers the possibility of revision if needed, unlike some other treatments that may involve more extensive bone removal. ^{1 2 4 6 9}

What is the purpose of 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.

Research Team

Jennifer Wolf, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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 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]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Early Results of the ARPE Arthroplasty Versus Trapeziectomy for the Treatment of Thumb Carpometacarpal Joint Osteoarthritis. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Nonsurgical Treatment of Thumb Carpometacarpal Osteoarthritis: A Cohort Study. [2023]

3. France pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Long-term results of arthrodesis of the carpometacarpal joint of the thumb. [2019]

5. Germany 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]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

The BioPro Thumb Carpometacarpal Hemiarthroplasty: Case Series and Surgical Technique. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Outcomes of denervation, joint lavage and capsular imbrication for painful thumb carpometacarpal joint osteoarthritis. [2022]

8. United States 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. [2021]

9. Turkey pubmed.ncbi.nlm.nih.gov

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