Hematoma Distraction Arthroplasty Versus Arthroscopic Trapeziectomy in Basal Thumb Arthritis
Primary Purpose
Orthopedic Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
wrist arthroscopy
Sponsored by
About this trial
This is an interventional other trial for Orthopedic Disorder
Eligibility Criteria
Inclusion Criteria: Age: adult patient > 20years. Gender: Males & Females. Symptomtic patient. Failed conservative treatment of 6 months duration Eaton stage II, III and IV of base thumb arthritis Exclusion Criteria: Patient presenting with flexor carpi radialis rupture Previous Zancolli arthroplasty Associated comorbidity as: RA,DM with joint destruction Infection Poor Skin Condition Active Pateint With High Joint Demand
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hematoma distraction
Arthroscopic
Arm Description
open Hematoma distraction
Arthroscopic Partial Trapeziectomy with Hematoma Distraction
Outcomes
Primary Outcome Measures
DASH score
score for pinch grip
Secondary Outcome Measures
Full Information
NCT ID
NCT05746091
First Posted
February 17, 2023
Last Updated
February 17, 2023
Sponsor
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT05746091
Brief Title
Hematoma Distraction Arthroplasty Versus Arthroscopic Trapeziectomy in Basal Thumb Arthritis
Official Title
Hematoma Distraction Arthroplasty Versus Arthroscopic Partial Trapeziectomy With Hematoma Distraction in Basal Thumb Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The basal joint, also referred to as the carpometacarpal (CMC) joint, of the thumb is one of the joints most commonly affected by arthritis. CMC joint arthritis can lead to decreased grip and pinch strength and impairment of activities of daily living
Detailed Description
The thumb CMC joint has been reported as the most painful joint when compared to other hand joints affected by OA. It is therefore no surprise that this is a common chief complaint of patients and has a significant effect on work and life satisfaction Patients often present with complaints of pain localized to the base of the thumb that is exacerbated when performing tasks such as opening a jar, turning a car key, and turning door Knob, this pain may be reproduced by resisted pinch and grip .
On physical examination, patients will have point tenderness at the thumb basal joint with swelling and crepitus when the basal joint is compressed - a positive grind test and a positive "hump" sign from dorsal CMC dislocation subluxation .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hematoma distraction
Arm Type
Active Comparator
Arm Description
open Hematoma distraction
Arm Title
Arthroscopic
Arm Type
Active Comparator
Arm Description
Arthroscopic Partial Trapeziectomy with Hematoma Distraction
Intervention Type
Procedure
Intervention Name(s)
wrist arthroscopy
Intervention Description
Hematoma Distraction Arthroplasty Versus Arthroscopic Partial Trapeziectomy with Hematoma Distraction in Basal Thumb Arthritis
Primary Outcome Measure Information:
Title
DASH score
Description
score for pinch grip
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: adult patient > 20years.
Gender: Males & Females.
Symptomtic patient.
Failed conservative treatment of 6 months duration
Eaton stage II, III and IV of base thumb arthritis
Exclusion Criteria:
Patient presenting with flexor carpi radialis rupture
Previous Zancolli arthroplasty
Associated comorbidity as: RA,DM with joint destruction
Infection
Poor Skin Condition
Active Pateint With High Joint Demand
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maysara Mohammed, MD
Phone
0201063119673
Email
maysarabayoumy.216@Azhar.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abbas, MD
Phone
0201067715777
Email
ahmedabbasmahmoud680@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Hematoma Distraction Arthroplasty Versus Arthroscopic Trapeziectomy in Basal Thumb Arthritis
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