Synovial Hypertrophy Hand (Diagnosis) Clinical Trial
Official title:
Prospective Study of Arthroscopic Diagnosis and Treatment of the Isolated Dorsal Wrist Syndrome in Patients With Hypertrophy of the Dorsal Synovial
| NCT number | NCT04648527 |
| Other study ID # | 20/31 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2021 |
| Est. completion date | January 2023 |
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.
| Status | Recruiting |
| Enrollment | 25 |
| Est. completion date | January 2023 |
| Est. primary completion date | January 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Dos de Maig, Consorci Sanitari Integral | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Consorci Sanitari Integral |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |