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Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis

Primary Purpose

Thumb Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
trapeziometacarpal limited excision
Trapeziectomy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thumb Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test).
  • Pain at rest.
  • Conservative treatment >6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection)

Exclusion Criteria:

  • Rheumatoid arthritis.
  • Ongoing infection in the hand or wrist. -
  • History of gout or pseudo gout.
  • Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
  • Intra-articular injection in the affected joint within 6 months.
  • Eaton Littler class 4 (STT joint involved).

Sites / Locations

  • Karolinska InstitutetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Trapeziectomy

trapeziometacarpal limited excision

Arm Description

Standard simple trapeziectomy, no pins.

Trapeziometacarpal limited excision; Narrow pseudarthrosis of the trapeziometacarpal joint.

Outcomes

Primary Outcome Measures

Change in pain on load NRS (numerical rating scale)
Change in rated pain on load from preoperatively to 1, 3 and 5 years postoperatively

Secondary Outcome Measures

Change in Nelson Thumb score
0-100 p, higher score = less disability
Change in EQ-5D
Weight mean value: 0=dead, 1= healthy
Change in DASH - Disability of the Arm, Shoulder and Hand
0-100 p, higher score = more disability
Change in PRWHE - Patient-Rated Wrist and Hand Evaluation
0-100 p, higher score = more disability
Change in HADS - Change hospital Anxiety and Depression score
2 subscores for anxiety (0-21P) and depression (0-21p), higher score = worse
Change in PCS - Pain Catastrophizing Score
0-52, higher score = more pain catastrophizing
Change in Thumb base motion
radial and palmar abduction of the first metacarpal (degrees).
Change in thumb strength
Key pinch and pinch strength (Kg)

Full Information

First Posted
December 19, 2019
Last Updated
October 10, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04210687
Brief Title
Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis
Official Title
A Randomized Comparison Between Trapeziectomy and Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

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 randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trapeziectomy
Arm Type
Active Comparator
Arm Description
Standard simple trapeziectomy, no pins.
Arm Title
trapeziometacarpal limited excision
Arm Type
Active Comparator
Arm Description
Trapeziometacarpal limited excision; Narrow pseudarthrosis of the trapeziometacarpal joint.
Intervention Type
Procedure
Intervention Name(s)
trapeziometacarpal limited excision
Intervention Description
Narrow pseudarthrosis CMC1
Intervention Type
Procedure
Intervention Name(s)
Trapeziectomy
Intervention Description
Simple trapeziectomy
Primary Outcome Measure Information:
Title
Change in pain on load NRS (numerical rating scale)
Description
Change in rated pain on load from preoperatively to 1, 3 and 5 years postoperatively
Time Frame
Preoperatively, 1, 3 and 5 years postoperatively
Secondary Outcome Measure Information:
Title
Change in Nelson Thumb score
Description
0-100 p, higher score = less disability
Time Frame
Preoperatively, 1, 3 and 5 years postoperatively
Title
Change in EQ-5D
Description
Weight mean value: 0=dead, 1= healthy
Time Frame
1, 3 and 5 years postoperatively
Title
Change in DASH - Disability of the Arm, Shoulder and Hand
Description
0-100 p, higher score = more disability
Time Frame
Preoperatively, 1, 3 and 5 years postoperatively
Title
Change in PRWHE - Patient-Rated Wrist and Hand Evaluation
Description
0-100 p, higher score = more disability
Time Frame
Preoperatively, 1, 3 and 5 years postoperatively
Title
Change in HADS - Change hospital Anxiety and Depression score
Description
2 subscores for anxiety (0-21P) and depression (0-21p), higher score = worse
Time Frame
Preoperatively, 1, 3 and 5 years postoperatively
Title
Change in PCS - Pain Catastrophizing Score
Description
0-52, higher score = more pain catastrophizing
Time Frame
Preoperatively, 1, 3 and 5 years postoperatively
Title
Change in Thumb base motion
Description
radial and palmar abduction of the first metacarpal (degrees).
Time Frame
Preoperatively, 1, 3 and 5 years postoperatively
Title
Change in thumb strength
Description
Key pinch and pinch strength (Kg)
Time Frame
Preoperatively, 1, 3 and 5 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test). Pain at rest. Conservative treatment >6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection) Exclusion Criteria: Rheumatoid arthritis. Ongoing infection in the hand or wrist. - History of gout or pseudo gout. Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). Intra-articular injection in the affected joint within 6 months. Eaton Littler class 4 (STT joint involved).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Wilcke, MD PhD
Phone
+46708294613
Ext
0708294613
Email
maria.wilcke@regionstockholm.se
First Name & Middle Initial & Last Name or Official Title & Degree
Kajsa Evans, MD
Email
kajsa.evans@regionstockholm.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Wilcke, MD PhD
Organizational Affiliation
Karolinska Instituet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
S-11883
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Wilcke, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis

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