Study Comparing SBS and LRTI for Treatment of CMC Arthritis

Official title

A Randomized Prospective Multicenter Study Comparing Suture Button Suspensionplasty (SBS) with Ligament Reconstruction and Tendon Interposition (LRTI)

Overview

A multi-center, randomized control trial comparing the two standard of care surgical treatments for CMC arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (LRTI) versus the suture button suspension arthroplasty (SBS). Patient reported outcomes will be collected at 6 and 6 weeks, 3, 6, and 12 months.

Detailed description

LRTI is a well established treatment of CMC arthritis with good results.However, comparable results have also been reported with SBS, with the latter procedure eliminating the need for flexor carpi radialis (FCR) harvest and interposition, resulting in potential shorter OR time and donor site morbidity. To date, there have been biomechanical studies comparing LRTI vs suture button suspension arthroplasty (SBS), and clinical studies comparing trapeziectomy alone vs SBS, but to the best of our knowledge, no random control studies comparing LRTI with SBS.The primary objective is to determine whether treatment with SBS results in improved overall pain relief compared to LRTI as measured by patient reported outcomes.Secondary outcome measures will be to determine if SBS results in shorter OR time and improved grip and pinch strength compared to LRTI, as well as have comparable return to work times and amount of radiographic shortening as shown on radiographs (metacarpal shortening has been felt to lead to decreased grip strength).

Interventions

• Procedure CMC Arthroplasty
  Surgical intervention to treat CMC arthritis

Primary outcome measures

• Visual Analog Scale- Pain [Time frame: 12 Months]
• Disabilities of the Arm, Shoulder and Hand Questionnaire [Time frame: 12 Months]
• Patient Related Wrist Evaluation Questionnaire [Time frame: 12 Months]

Secondary outcome measures (4)

• Operative Time [Time frame: Intraoperative]
• Strength [Time frame: 12 Months]
• Range of Motion [Time frame: 12 Months]
• Work Productivity and Activity Impairment: Specific Health Problem Questionnaire [Time frame: 12 Months]

Eligibility criteria

Inclusion criteria

• Age fifty years or older
• Isolated carpometacarpal (trapeziometacarpal) osteoarthritis
• Failure to respond to non-operative management
• Willing and able to consent on their own behalf and follow the protocol and clinical visits as described
• Able to read and understand English or have interpreter available

Exclusion criteria

• Previous surgery for CMC arthritis
• Duration of symptoms for less than 6 months
• Greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (MCP) hyperextension
• Scaphotrapeziotrapezoidal (stage 4 CMC) arthritis
• Other significant ipsilateral wrist or hand pathology
• A history of inflammatory arthropathy
• A requirement for concomitant surgery for another condition
• Any previous hand or wrist fracture
• Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 2 centers

• South Campus Research Unit for Bone and Soft Tissue — Calgary
• Fraser Orthopaedic Research Society — New Westminster

Identifiers

NCT: NCT05111405 · FHREB # 2021-112

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗