Hematoma Distraction Arthroplasty Versus Arthroscopic Trapeziectomy in Basal Thumb Arthritis

• Sponsor: Al-Azhar University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05746091
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 27

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Disorder	Procedure: wrist arthroscopy	N/A

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 .

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• Official Title: Hematoma Distraction Arthroplasty Versus Arthroscopic Partial Trapeziectomy With Hematoma Distraction in Basal Thumb Arthritis
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hematoma distraction open Hematoma distraction	Procedure: wrist arthroscopy; Hematoma Distraction Arthroplasty Versus Arthroscopic Partial Trapeziectomy with Hematoma Distraction in Basal Thumb Arthritis
Active Comparator: Arthroscopic Arthroscopic Partial Trapeziectomy with Hematoma Distraction	Procedure: wrist arthroscopy; Hematoma Distraction Arthroplasty Versus Arthroscopic Partial Trapeziectomy with Hematoma Distraction in Basal Thumb Arthritis

Outcome Measures

Primary Outcome Measures

1. DASH score [1 year]

   score for pinch grip

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Abbas Mahmoud, principal investigator, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05746091
• Other Study ID Numbers: HDVAT
• First Posted: Feb 27, 2023
• Last Update Posted: Feb 27, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Musculoskeletal Diseases; Hematoma

Study Results

No Results Posted as of Feb 27, 2023