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Arthroscopic Diagnosis and Treatment of Dorsal Wrist Syndrome in Patients With Synovial Hypertrophy

Primary Purpose

Synovial Hypertrophy Hand (Diagnosis)

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
arthroscopic synovectomy and thermocoagulation
Sponsored by
Consorci Sanitari Integral
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Synovial Hypertrophy Hand (Diagnosis) focused on measuring wrist, arthroscopy, synovectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men or women
  2. Age 18-65 years old, both included
  3. Diagnose of primary dorsal wrist syndrome, defined as:

    3.1 Radiocarpal dorsal focal pain 3.2 Pain increases in hyperextension of the wrist and in axial load 3.3 X-rays and MRI without significant findings 3.4 Watson test, extension finger test, Kleinman shuck test, distal radio-ulnar ballottement test, fovea sign all of them negatives and absence of tenosynovitis of the extensor tendons.

  4. Refractory to conservative treatment consisting in at least 3 months of physical therapy.
  5. Presence of a hypertrophy of the dorsal synovial of the wrist diagnosed through direct visualization in wrist arthroscopy.
  6. Other diagnoses excluded through wrist arthroscopy

Exclusion Criteria:

  1. Hand or wrist fractures
  2. Arthritis
  3. Carpal boss
  4. Scapho-lunate ligament tears
  5. Luno-triquetral ligament tears
  6. Triangular fibrocartilage tears
  7. Bone necrosis
  8. Systemic arthritis as rheumatoid arthritis, psoriasic arthritis, gouty arthritis, etc.)
  9. Dorsal or volar ganglions
  10. Distal radio-ulnar joint injury or instability
  11. Hand or wrist infections or tumors

Sites / Locations

  • Hospital Dos de Maig, Consorci Sanitari IntegralRecruiting

Outcomes

Primary Outcome Measures

Changes in the Mayo wrist score
Assessment of the changes of Mayo score, before the intervention and at 3 months, 6 months and 12 months after the intervention. The Mayo wrist score ranges from 0 to 100 with a score of 0 indicating a worse wrist condition and 100 indicating a better wrist condition.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2020
Last Updated
November 23, 2020
Sponsor
Consorci Sanitari Integral
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1. Study Identification

Unique Protocol Identification Number
NCT04648527
Brief Title
Arthroscopic Diagnosis and Treatment of Dorsal Wrist Syndrome in Patients With Synovial Hypertrophy
Official Title
Prospective Study of Arthroscopic Diagnosis and Treatment of the Isolated Dorsal Wrist Syndrome in Patients With Hypertrophy of the Dorsal Synovial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consorci Sanitari Integral

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective of the study is to evaluate de results of the arthroscopic diagnose and arthroscopic treatment of the dorsal wrist pain syndrome associated with dorsal synovial hypertrophy. It is a prospective study of 25 consecutive patients with the diagnosis of dorsal wrist radiographies and MRI) have discarded other concomitant pathologies. After being refractory to the conservative measures consisting in physiotherapy for at least 3 months, a wrist arthroscopy will be performed with diagnostic and treatment objectives. All these procedures will be performed by the same surgical team. Only will be included those patients whose diagnostic arthroscopy show absence of other concomitant lesions as scapho-lunate or luno-triquetral tears, triangular fibrocartilage injuries, chondral injuries, fractures, arthritis or other injuries that will be considered as exclusion criteria. In those cases where a hypertrophy of the dorsal synovial is confirmed, an arthroscopic synovectomy and radiofrequency thermocoagulation of the hypertrophic synovial will be performed. The standard radiocarpal portals for wrist arthroscopy will be performed: 3-4 portal and 6-R portal. The pain syndrome described as dorsal localized wrist pain, especially reproductible in hyperextension and axial load of the wrist and in whom the complementary tests (plain The following data will be reviewed and analyzed: age, sex, right/left wrist, right/left-handed, anamnesis, physical exam, MRI findings, arthroscopic diagnosis and functional outcome through Mayo score as a main viable and also, VAS(visual analogue scale for pain), DASH score, grip strength measured with jamar dynamometer and articular balance. All these parameters will be registered pre-surgery and post-surgery at 6 weeks, 3 months and 12 months of the follow-up and at the end of follow-up. The minimum follow-up will be at least of 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Synovial Hypertrophy Hand (Diagnosis)
Keywords
wrist, arthroscopy, synovectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective before-and-after study
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
arthroscopic synovectomy and thermocoagulation
Intervention Description
An diagnostic arthroscopy and an arthroscopic synovectomy and thermocoagulation of the dorsal hypertrophic synovial will be performed
Primary Outcome Measure Information:
Title
Changes in the Mayo wrist score
Description
Assessment of the changes of Mayo score, before the intervention and at 3 months, 6 months and 12 months after the intervention. The Mayo wrist score ranges from 0 to 100 with a score of 0 indicating a worse wrist condition and 100 indicating a better wrist condition.
Time Frame
Before intervention, 3 months after intervention, 6 months after intervention, 12 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women Age 18-65 years old, both included Diagnose of primary dorsal wrist syndrome, defined as: 3.1 Radiocarpal dorsal focal pain 3.2 Pain increases in hyperextension of the wrist and in axial load 3.3 X-rays and MRI without significant findings 3.4 Watson test, extension finger test, Kleinman shuck test, distal radio-ulnar ballottement test, fovea sign all of them negatives and absence of tenosynovitis of the extensor tendons. Refractory to conservative treatment consisting in at least 3 months of physical therapy. Presence of a hypertrophy of the dorsal synovial of the wrist diagnosed through direct visualization in wrist arthroscopy. Other diagnoses excluded through wrist arthroscopy Exclusion Criteria: Hand or wrist fractures Arthritis Carpal boss Scapho-lunate ligament tears Luno-triquetral ligament tears Triangular fibrocartilage tears Bone necrosis Systemic arthritis as rheumatoid arthritis, psoriasic arthritis, gouty arthritis, etc.) Dorsal or volar ganglions Distal radio-ulnar joint injury or instability Hand or wrist infections or tumors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camila Chanes Puiggrós, MD
Phone
+34935072700
Email
cami.chanes@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camila Chanes Puiggrós, MD
Organizational Affiliation
Hospital Dos de Maig, Consorci Sanitari Integral
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Dos de Maig, Consorci Sanitari Integral
City
Barcelona
ZIP/Postal Code
E-08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camila Chanes, MD
Phone
+34935072700
Email
cami.chanes@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Arthroscopic Diagnosis and Treatment of Dorsal Wrist Syndrome in Patients With Synovial Hypertrophy

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