An interventional study of arthroscopic synovectomy and thermocoagulation in Synovial Hypertrophy Hand (Diagnosis), sponsored by Consorci Sanitari Integral. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-12-01.
Sponsored by Consorci Sanitari Integral · Not applicable, Interventional, and Treatment
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.
Consorci Sanitari Integral is the lead sponsor of 16 studies on the registry; 5 are open to participants now.
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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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An diagnostic arthroscopy and an arthroscopic synovectomy and thermocoagulation of the dorsal hypertrophic synovial will be performed
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.
Time frame: Before intervention, 3 months after intervention, 6 months after intervention, 12 months after intervention
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2021; primary completion for Jan 2022, 12 months later.
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This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Consorci Sanitari Integral