Ligament Reconstruction in an Accelerated Rehabilitation Protocol

October 4, 2022 updated by: Dr. David Pichora

Accelerated vs Traditional Rehabilitation Protocol Following Ligament Reconstruction Tendon Interposition Surgery Using Interference Screw Fixation for 1st CMC Arthritis .

The investigators have found that their patients who get earlier rehabilitation following ligament reconstruction and tendon interposition (LRTI) surgery with interference screws have experienced better outcomes. The investigators hypothesis is that when formally comparing these patients who are exposed to the rehabilitation protocol earlier compared to later, the investigators will see statistically better outcomes.

Study Overview

Status

Status

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Withdrawn

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.

Detailed Description

Osteoarthritis (OA) of the 1st carpometacarpal (CMC) joint is a significant cause of hand pain, dysfunction, disability, and visible deformity. Surgery in the form of ligament reconstruction and tendon interposition (LRTI)is often indicated when less invasive procedures fail. Following LRTI procedures, the accepted classic protocol throughout the literature has been to place patients in a thumb-immobilizing spica cast or splint for 4-6 weeks and then begin rehabilitation exercises. Following this, a gradual progressive rehabilitation protocol is initiated which usually focuses on thumb range of motion, pinch strength, and hand function. This standard form of rehabilitation has shown improvements in pain, function, and satisfaction. However, because these patients are usually kept immobilized until 4-6 weeks post-operatively in order for the tendon graft to incorporate and become stable, stiffness can develop in the thumb as a result. This leads to more time off work and without full and unrestricted use of the hand. Due to their higher pullout strength compared to conventional tendon fixation, the use of interference screws in LRTI procedures may allow for earlier initiation of a more accelerated rehabilitation protocol compared to the standard 4-6 weeks of immobilization prior to rehabilitation. Over the past year at the investigators center the investigators have begun post-operative mobilization and rehabilitation on the first post-op visit at 10-14 days following LRTI with the use of an interference screw. Anecdotally, the investigators have found that their patients have regained their range of motion and function earlier and, in some cases, with larger gains compared to their previous patients they had immobilized for 6 weeks before initiating their rehabilitation. The purpose of this study is to compare patients that have been exposed to the early versus standard rehabilitation protocol to see if there is significant improvement in their range of motion, pinch and grip strength, pain levels and function.

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.
Observational

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Hotel Dieu Hospital

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

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

  • clinical and radiographic diagnosis of 1st CMC OA
  • failed to improve with conservative modalities
  • continued pain over the first CMC joint
  • loss of strength or motion of the thumb that limits activities of daily living

Exclusion Criteria:

  • rheumatoid arthritis
  • gout
  • cervical radiculopathy
  • previous thumb/1st CMC surgery
  • post-traumatic arthritis of 1st CMC
  • carpal tunnel syndrome with motor function impairment
  • patients with post-traumatic arthritis of their 1st CMC AND have dislocation of this joint.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
fast rehabilitation program
conventional rehabilitation
Behavioral: Fast rehabilitation program
1-2 weeks (first post-op visit): Long thumb spica splint removed; Staples/stitches removed; Short hand-based thumb spica fitted for the patient Start Active Range of Motion Exercises (AROM) for thumb Add active assisted rang of motion exercises (AAROM) if no significant progress 6 weeks: Gradually wean off of splint during the day; wear for protection and/or more strenuous daily activities 6-8 weeks: Passive Range of Motion Exercises (PROM) (ie. stretching), if needed - (ie. No significant changes in ROM of thumb) 8-10 weeks: Resisted exercises/activities without splint on

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
Pinch strength
Time Frame: 6 weeks
standard hydraulic hand dynamometer
6 weeks

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
range of motion
Time Frame: 6 weeks
range of hand motion
6 weeks

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
Visual analog scale
Time Frame: 6 weeks
pain measurement
6 weeks
first metacarpal height as measured on xray image
Time Frame: 6 weeks
measured in mm
6 weeks

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.
Dr. David Pichora

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.
  • Principal Investigator: David Pichora, MD, Queen's University

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.
February 1, 2014

Primary Completion (Actual)

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.
April 1, 2017

Study Completion (Actual)

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.
April 1, 2017

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).
April 24, 2014

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.
October 4, 2022

First Posted (Actual)

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.
October 7, 2022

Study Record Updates

Last Update Posted (Actual)

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.
October 7, 2022

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.
October 4, 2022

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.
October 1, 2022

More Information

Terms related to this study

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.
  • SURG-288-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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