Ligament Reconstruction in an Accelerated Rehabilitation Protocol

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• Status: Withdrawn
• Conditions: Osteoarthritis
• Intervention / Treatment: Behavioral: Fast rehabilitation program

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: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Pinch strength	standard hydraulic hand dynamometer	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion	range of hand motion	6 weeks

Other Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: SURG-288-14