Thumb Metacarpophalangeal Hyperextension in an Arthritic Population; Part 2

NCT05835830 | Unknown

• 1 other identifier: MP Hyperextension
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is the second phase of a clinical study to assess MP hyperextension in CMC arthritis. In the first phase, submitted for publication, the investigators demonstrated that there is poor correlation between dynamic control of the MP joint and the amount of passive hyperextension preoperatively in a sample of patients with CMC arthritis.

Conditions

CMC Arthritis

Outcome Measures

Primary Outcomes (3)

• Passive Thumb MP Hyperextension

  degree of MP Hyperextension measured in clinic

  12 months

• Dynamic thumb MP Hyperextension (key pinch)

  lateral key pinch measured with pinch gauge

  12 months

• Dynamic thumb MP position during cylindrical grasp

  range of motion measure of thumb MP joint around a cylindrical object (peanut butter jar and water bottle)

  12 months

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting in clinic with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis will be screened for participation in study.

You may qualify if:

• Adults (18 years of age or older)
• Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis
• Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays
• Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study
• Patients with greater than 20 degrees of passive MP Hyperextension
• o Screened by surgeons upon first evaluation in clinic
• Bilateral thumbs included

You may not qualify if:

• \<18 years age
• Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb MP or CMC joints
• Prior ipsilateral 1st ray deformity or malunion, distal radial malunion or nonunion, 2nd ray amputation or deformity
• Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy
• Inflammatory arthritis
• Post-traumatic CMC arthritis
• Prior trauma to the MP or CMC joints
• Diagnosis of Ehler-Danlos syndrome or other connective tissue disorder
• Concomitant treatment of the MP joint

Sponsors & Collaborators

• Indiana Hand to Shoulder Center: lead

Study Sites (1)

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: October 6, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)