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

NCT04648527 | Unknown

• 1 other identifier: 20/31
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Synovial Hypertrophy Hand (Diagnosis)

Keywords

wrist; arthroscopy; synovectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Before intervention, 3 months after intervention, 6 months after intervention, 12 months after intervention

Interventions

arthroscopic synovectomy and thermocoagulation PROCEDURE

An diagnostic arthroscopy and an arthroscopic synovectomy and thermocoagulation of the dorsal hypertrophic synovial will be performed

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Sanitari Integral: lead

Study Sites (1)

Hospital Dos de Maig, Consorci Sanitari Integral

Barcelona, E-08025, Spain

RECRUITING

MeSH Terms

Conditions

Disease

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Camila Chanes Puiggrós, MD

  Hospital Dos de Maig, Consorci Sanitari Integral

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camila Chanes Puiggrós, MD

CONTACT

+34935072700; cami.chanes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective before-and-after study

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 1, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)