Clinical Trials Logo
  1. Home
  2. Arthritis
  3. NCT02591368

MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis

Arthritis Clinical Trial

Official title:
MiniTightRope Suspensionplasty Compared With Ligamentous Reconstruction Tendon Interposition for the Treatment of Basilar Thumb Arthritis. A Randomized Clinical Trial

Clinical Trial Summary

This prospective randomized trial aims to ascertain differences in outcome measures for the operative treatment of basilar thumb arthritis by comparing the two most common surgical treatments: LRTI and mini tightrope suspensionplasty. The Investigators will evaluate both subjective and objective data to determine if a particular surgical method offers more favorable outcomes.

Clinical Trial Description

The study will be a prospective randomized-controlled trial comparing LRTI and mini tightrope suspensionplasty for the surgical treatment of basilar thumb arthritis. Patients meeting operative criteria who present to Level One Orthopaedics at Orlando Health will be consented for study participation. Subsequently, consented patients will be randomized into one of three treatment arms: LRTI, suspensionplasty with one-suture construct and suspensionplasty with two-suture construct. The patient will be blinded prior to the procedure; however, the performing surgeon will not be able to be blinded. The patient will become un-blinded postoperatively when the performing surgeon informs them which method was used. The investigators will then follow the patients for 5 years to assess the primary and secondary outcomes (see below) and analyze the data with an intention-to-treat method before publishing the conclusions. Follow-up visits will occur at two weeks, one month, three months, six months, one year, and five years. Outcome measures will incorporate subjective and objective measures and will include the SF-36 and Disabilities of Arm, Shoulder & Hand (DASH) questionnaires, pinch/grip strength, visual analog pain scale, patient satisfaction and postoperative complications. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02591368
Study type Interventional
Source Orlando Health, Inc.
Contact
Status Terminated
Phase N/A
Start date October 2015
Completion date October 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT04228458 - ThermRheum Version 1 N/A
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT04037436 - Functional Exercise and Nutrition Education Program for Older Adults N/A
Completed NCT00069342 - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed NCT02944448 - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee Phase 2
Recruiting NCT02498808 - Interferon-lambda: Novel Biologics for Controlling Neutrophil-mediated Pathology in Rheumatic Diseases? N/A
Recruiting NCT02777060 - Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures N/A
Enrolling by invitation NCT02487888 - A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care N/A
Withdrawn NCT02136251 - Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.
Completed NCT02143206 - Modifying Exercise for the COPD Patient
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT01285843 - Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component N/A
Completed NCT01172327 - Self-Directed Exercise Program for Adults With Arthritis N/A
Completed NCT00987870 - Safety and Efficacy of BFH772 in Psoriasis Patients Phase 1/Phase 2
Completed NCT00750984 - A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing N/A
Completed NCT01184924 - Evaluation of the Arthritis Foundation Tai Chi Program N/A
Active, not recruiting NCT00611585 - A Safety and Efficacy Study of the Birmingham Hip Resurfacing System N/A
Completed NCT00379184 - Sensitization in Osteoarthritic Knees N/A
Completed NCT00175448 - Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery N/A
Completed NCT00403676 - Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease N/A