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Postoperative Therapy After Interposition Arthroplasty in CMC1

Primary Purpose

Thumb Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Early mobilisation after CMC1-surgery
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thumb Osteoarthritis focused on measuring Osteoarthritis, CMC1-joint, Postoperative therapy, Interposition arthroplasty of the thumb, Occupational therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Osteoarthritis in CMC1 diagnosed by radiography and a surgeon.
  • Planned surgery(interposition arthroplasty) in CMC1
  • Ability to communicate in Norwegian

Exclusion Criteria:

  • Surgery involving other joints of the hand in addition to CMC1.
  • Previous surgery of the same thumb.
  • Other diseases og injuries that could influence hand function.
  • Mental or cognitive deficit.

Sites / Locations

  • Diakonhjemmet hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Early mobilisation after CMC1-surgery

Conservative treatment after CMC1-surgery

Arm Description

Mobilisation at two weeks after operation. The participants will wear a soft splint for six weeks.

Current standard procedure: Mobilisation at six weeks after operation. The participants will wear a rigid splint for six weeks.

Outcomes

Primary Outcome Measures

Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months.
The COPM-assessment starts with an interview, addressing patient specific Hand Osteoarthritis (HOA)-related activity limitations within the areas self-care, productivity and leisure. The patient will thereafter rate the five most important activities for performance and satisfaction with performance, on 1 to 10-point scales (higher scores reflect better performance or higher satisfaction). The Norwegian version of the COPM has been tested for validity, reliability and responsiveness and has demonstrated good ability to detect functional changes in HOA.
Change from baseline in Patient satisfaction with the rehabilitation regimen at 3, 6 and 12 months.
Each patient will be asked to complete a Numeric Rating Scale in order to give an opinion about their postoperative treatment regimen (splint-use, hand function, pain in the thumb, thumb movement and satisfaction with the operation).

Secondary Outcome Measures

Measure for activity performance (MAP-hand).
MAP-hand is a questionnaire consisting of questions about 18 standardised activities. The patients will be instructed to score their ability to perform the activities on a scale from 1(No difficulty)to 4 (Not able to do). The Norwegian version of the MAP-hand has been tested for validity, reliability and responsiveness.
Grip force and pinch grip
The electronical instrument Grippit will be used to measure grip force and pinch grip. In Grippit, force recordings in Newtons (N) are displayed on the electronic unit every 0.5 seconds over a period of 10 seconds. The peak and average of the 20 registrations, as well as the final value (last recording) will be recorded.
Joint mobility
The flexion deficit of fingers 2 - 5 will be assessed by measuring the distance between the distal nail and the proximal crease inside the hand in millimeters. Range of motion in the thumbs metacarpophalangeal and interphalangeal joints will be measured with a goniometer. The palmar abduction of the CMC1 and of the entire thumb will be measured with the Pollexograph.
Pain
Pain will be measured on a numeric rating scale (NRS), (0-10, 0=no pain), by asking the patients to mark the level of pain experienced both while they are resting and during resisted motion when measuring grip force and pinch grip.

Full Information

First Posted
August 23, 2012
Last Updated
May 4, 2015
Sponsor
Diakonhjemmet Hospital
Collaborators
The Norwegian Women´s Public Health Association
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1. Study Identification

Unique Protocol Identification Number
NCT01679717
Brief Title
Postoperative Therapy After Interposition Arthroplasty in CMC1
Official Title
Postoperative Therapy After Interposition Arthroplasty in CMC1
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diakonhjemmet Hospital
Collaborators
The Norwegian Women´s Public Health Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this randomized controlled trial the investigators want to investigate whether early versus late mobilisation after surgery in the first carpometacarpal joint (CMC1) leads to a faster recovery of hand function. The investigators also want to explore patients' satisfaction with the two different treatment regimes. The participants in the control group will receive the standard treatment at Diakonhjemmet hospital: immobilisation of the thumb in a splint for six weeks. The participants in the intervention group will use a soft splint for six weeks, but will be instructed to remove the splint daily to perform exercises for the thumb. A total of 70 patients will be included in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis
Keywords
Osteoarthritis, CMC1-joint, Postoperative therapy, Interposition arthroplasty of the thumb, Occupational therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early mobilisation after CMC1-surgery
Arm Type
Active Comparator
Arm Description
Mobilisation at two weeks after operation. The participants will wear a soft splint for six weeks.
Arm Title
Conservative treatment after CMC1-surgery
Arm Type
Other
Arm Description
Current standard procedure: Mobilisation at six weeks after operation. The participants will wear a rigid splint for six weeks.
Intervention Type
Other
Intervention Name(s)
Early mobilisation after CMC1-surgery
Intervention Description
Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.
Primary Outcome Measure Information:
Title
Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months.
Description
The COPM-assessment starts with an interview, addressing patient specific Hand Osteoarthritis (HOA)-related activity limitations within the areas self-care, productivity and leisure. The patient will thereafter rate the five most important activities for performance and satisfaction with performance, on 1 to 10-point scales (higher scores reflect better performance or higher satisfaction). The Norwegian version of the COPM has been tested for validity, reliability and responsiveness and has demonstrated good ability to detect functional changes in HOA.
Time Frame
Baseline, 3, 6 and 12 months
Title
Change from baseline in Patient satisfaction with the rehabilitation regimen at 3, 6 and 12 months.
Description
Each patient will be asked to complete a Numeric Rating Scale in order to give an opinion about their postoperative treatment regimen (splint-use, hand function, pain in the thumb, thumb movement and satisfaction with the operation).
Time Frame
Baseline, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Measure for activity performance (MAP-hand).
Description
MAP-hand is a questionnaire consisting of questions about 18 standardised activities. The patients will be instructed to score their ability to perform the activities on a scale from 1(No difficulty)to 4 (Not able to do). The Norwegian version of the MAP-hand has been tested for validity, reliability and responsiveness.
Time Frame
Baseline, 3, 6 and 12 months
Title
Grip force and pinch grip
Description
The electronical instrument Grippit will be used to measure grip force and pinch grip. In Grippit, force recordings in Newtons (N) are displayed on the electronic unit every 0.5 seconds over a period of 10 seconds. The peak and average of the 20 registrations, as well as the final value (last recording) will be recorded.
Time Frame
Baseline, 3, 6 and 12 months
Title
Joint mobility
Description
The flexion deficit of fingers 2 - 5 will be assessed by measuring the distance between the distal nail and the proximal crease inside the hand in millimeters. Range of motion in the thumbs metacarpophalangeal and interphalangeal joints will be measured with a goniometer. The palmar abduction of the CMC1 and of the entire thumb will be measured with the Pollexograph.
Time Frame
Baseline, 3, 6 and 12 months
Title
Pain
Description
Pain will be measured on a numeric rating scale (NRS), (0-10, 0=no pain), by asking the patients to mark the level of pain experienced both while they are resting and during resisted motion when measuring grip force and pinch grip.
Time Frame
Baseline, 3, 6, and 12 months
Other Pre-specified Outcome Measures:
Title
Training diary
Description
The patients will be asked to report which date they performed exercises, which exercises they performed and how much pain they experienced after performing the exercises. They will also be encouraged to write down their own comments /reflections regarding the training.
Time Frame
Intervention group: 2-6 weeks and 3-4 months. Control group: 6-10 weeks and 3-4 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Osteoarthritis in CMC1 diagnosed by radiography and a surgeon. Planned surgery(interposition arthroplasty) in CMC1 Ability to communicate in Norwegian Exclusion Criteria: Surgery involving other joints of the hand in addition to CMC1. Previous surgery of the same thumb. Other diseases og injuries that could influence hand function. Mental or cognitive deficit.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tove Nilsen, MSc
Phone
+47 22451500
Email
tove.nilsen@diakonsyk.no
First Name & Middle Initial & Last Name or Official Title & Degree
Ingvild Kjeken, PhD
Phone
+47 22451500
Email
ingvild.kjeken@diakonsyk.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingvild Kjeken, Ph.d
Organizational Affiliation
Department of Rheumatology, Diakonhjemmet hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Diakonhjemmet hospital
City
Oslo
ZIP/Postal Code
N-0370
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tove Nilsen, MSc
Phone
+47 22451500
Email
tove.nilsen@diakonsyk.no
First Name & Middle Initial & Last Name & Degree
Ingvild Kjeken, PhD
Phone
+47 22451500
Email
ingvild.kjeken@diakonsyk.no
First Name & Middle Initial & Last Name & Degree
Tove Nilsen, MSc

12. IPD Sharing Statement

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Postoperative Therapy After Interposition Arthroplasty in CMC1

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