Postoperative Therapy After Interposition Arthroplasty in CMC1

May 4, 2015 updated by: Tove Nilsen, Diakonhjemmet Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Early mobilisation after CMC1-surgery
Mobilisation at two weeks after operation. The participants will wear a soft splint for six weeks.
Other: Early mobilisation after CMC1-surgery
Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.
Other: Conservative treatment after CMC1-surgery
Current standard procedure: Mobilisation at six weeks after operation. The participants will wear a rigid splint for six weeks.
Other: Early mobilisation after CMC1-surgery
Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months.
Time Frame: Baseline, 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.
Baseline, 3, 6 and 12 months
Change from baseline in Patient satisfaction with the rehabilitation regimen at 3, 6 and 12 months.
Time Frame: Baseline, 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).
Baseline, 3, 6 and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measure for activity performance (MAP-hand).
Time Frame: Baseline, 3, 6 and 12 months
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.
Baseline, 3, 6 and 12 months
Grip force and pinch grip
Time Frame: Baseline, 3, 6 and 12 months
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.
Baseline, 3, 6 and 12 months
Joint mobility
Time Frame: Baseline, 3, 6 and 12 months
  • 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.
Baseline, 3, 6 and 12 months
Pain
Time Frame: Baseline, 3, 6, and 12 months
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.
Baseline, 3, 6, and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Training diary
Time Frame: Intervention group: 2-6 weeks and 3-4 months. Control group: 6-10 weeks and 3-4 months.
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.
Intervention group: 2-6 weeks and 3-4 months. Control group: 6-10 weeks and 3-4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Diakonhjemmet Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Norwegian Women´s Public Health Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ingvild Kjeken, Ph.d, Department of Rheumatology, Diakonhjemmet Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H4/2012

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