search
Back to results

Study Comparing SBS and LRTI for Treatment of CMC Arthritis (SBSvsLRTI)

Primary Purpose

Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CMC Arthroplasty
Sponsored by
Fraser Orthopaedic Research Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • Fraser Orthopaedic Research SocietyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Trapezial excision with or without soft tissue interposition and /or ligament reconstruction

Suture button suspension arthroplasty (SBS)

Arm Description

The participating surgeon will perform their usual version of a trapeziectomy and thumb metacarpal using either FCR tendon or abductor hallucis longs (APL) tendon. Tendon interposition will be left to the surgeon's discretion.

Dorso-radial incision, capsulotomy between extensor pollicis brevis (EPB) and APL protecting the radial artery. A second incision is made on dorsum of hand between the 2nd and 3rd MCs. A cannulated drill with suture passer is passed from base of 1st MC to mid 2nd MC. The TightropeTM is passed from 1st to second MC with one button on the base of the 1st MC. Trapeziectomy is then performed using a cruciate osteotomy and rongeurs. The thumb is adducted against index MC to avoid excessive tightening and the suture is tied over a second button on the 2nd MC. Closure of capsule with Vicryl. Closure of skin with running Prolene suture.

Outcomes

Primary Outcome Measures

Visual Analog Scale- Pain
Participants overall assessment of their pain at maximal key pinch loading on a 10 cm visual analogue scale
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.
Patient Related Wrist Evaluation Questionnaire
A 15 item questionnaire to measure wrist pain and disability pain in activities of daily living

Secondary Outcome Measures

Operative Time
Time as recorded from the surgeons start of the procedure until the surgeons stop.
Strength
Transverse volar grip strength as measured by a dynamometer and key and lateral pinch strength measure by a pinch gauge
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.
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.

Full Information

First Posted
October 27, 2021
Last Updated
September 11, 2023
Sponsor
Fraser Orthopaedic Research Society
search

1. Study Identification

Unique Protocol Identification Number
NCT05111405
Brief Title
Study Comparing SBS and LRTI for Treatment of CMC Arthritis
Acronym
SBSvsLRTI
Official Title
A Randomized Prospective Multicenter Study Comparing Suture Button Suspensionplasty (SBS) With Ligament Reconstruction and Tendon Interposition (LRTI)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fraser Orthopaedic Research Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Multicenter, randomized, prospective trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trapezial excision with or without soft tissue interposition and /or ligament reconstruction
Arm Type
Other
Arm Description
The participating surgeon will perform their usual version of a trapeziectomy and thumb metacarpal using either FCR tendon or abductor hallucis longs (APL) tendon. Tendon interposition will be left to the surgeon's discretion.
Arm Title
Suture button suspension arthroplasty (SBS)
Arm Type
Other
Arm Description
Dorso-radial incision, capsulotomy between extensor pollicis brevis (EPB) and APL protecting the radial artery. A second incision is made on dorsum of hand between the 2nd and 3rd MCs. A cannulated drill with suture passer is passed from base of 1st MC to mid 2nd MC. The TightropeTM is passed from 1st to second MC with one button on the base of the 1st MC. Trapeziectomy is then performed using a cruciate osteotomy and rongeurs. The thumb is adducted against index MC to avoid excessive tightening and the suture is tied over a second button on the 2nd MC. Closure of capsule with Vicryl. Closure of skin with running Prolene suture.
Intervention Type
Procedure
Intervention Name(s)
CMC Arthroplasty
Intervention Description
Surgical intervention to treat CMC arthritis
Primary Outcome Measure Information:
Title
Visual Analog Scale- Pain
Description
Participants overall assessment of their pain at maximal key pinch loading on a 10 cm visual analogue scale
Time Frame
12 Months
Title
Disabilities of the Arm, Shoulder and Hand Questionnaire
Description
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.
Time Frame
12 Months
Title
Patient Related Wrist Evaluation Questionnaire
Description
A 15 item questionnaire to measure wrist pain and disability pain in activities of daily living
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Operative Time
Description
Time as recorded from the surgeons start of the procedure until the surgeons stop.
Time Frame
Intraoperative
Title
Strength
Description
Transverse volar grip strength as measured by a dynamometer and key and lateral pinch strength measure by a pinch gauge
Time Frame
12 Months
Title
Range of Motion
Description
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.
Time Frame
12 Months
Title
Work Productivity and Activity Impairment: Specific Health Problem Questionnaire
Description
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.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bertrand Perey
Phone
604-553-3247
Email
bperey@shaw.ca
Facility Information:
Facility Name
Fraser Orthopaedic Research Society
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 0E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand Perey, MD
Phone
604-553-3247
First Name & Middle Initial & Last Name & Degree
Kyrsten Payne, BSc
Phone
604-553-3247
Email
kyrsten.payne@fraserhealth.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study Comparing SBS and LRTI for Treatment of CMC Arthritis

We'll reach out to this number within 24 hrs