Study Comparing SBS and LRTI for Treatment of CMC Arthritis

Arthritis Clinical Trial

— SBSvsLRTI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05111405
• Other study ID #: FHREB # 2021-112
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Fraser Orthopaedic Research Society
• Contact: Bertrand Perey
• Phone: 604-553-3247
• Email: bperey[@]shaw.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Arthritis

Intervention

Procedure:
• CMC Arthroplasty
Surgical intervention to treat CMC arthritis

Locations

Country	Name	City	State
Canada	South Campus Research Unit for Bone and Soft Tissue	Calgary	Alberta
Canada	Fraser Orthopaedic Research Society	New Westminster	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Orthopaedic Research Society

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale- Pain	Participants overall assessment of their pain at maximal key pinch loading on a 10 cm visual analogue scale	12 Months
Primary	Disabilities of the Arm, Shoulder and Hand Questionnaire	A 30 Item questionnaire that measures an individuals' ability to complete tasks, absorb forces and severity of symptoms. Lower scores will indicated better outcomes.Lower scores will indicate better outcomes.	12 Months
Primary	Patient Related Wrist Evaluation Questionnaire	A 15 item questionnaire to measure wrist pain and disability pain in activities of daily living	12 Months
Secondary	Operative Time	Time as recorded from the surgeons start of the procedure until the surgeons stop.	Intraoperative
Secondary	Strength	Transverse volar grip strength as measured by a dynamometer and key and lateral pinch strength measure by a pinch gauge	12 Months
Secondary	Range of Motion	Thumb flexion will be measured from the top of the thumb (pulp) to the base of the 5th metacarpal (pinky finger). Retropulsion measured as the distance between the thumb and table when the dorsum of the hand is pressed against the table.	12 Months
Secondary	Work Productivity and Activity Impairment: Specific Health Problem Questionnaire	A questionnaire pertaining to the effect of the participant's CMC arthritis on their ability to work and perform regular activities. Lower scores will indicate better outcomes.	12 Months