OsteoarthritisNCT05571241
Ligament Reconstruction in an Accelerated Rehabilitation Protocol
An observational study of Osteoarthritis, run by Dr. David Pichora at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Fast rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Fast rehabilitation program
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast rehabilitation programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| fast rehabilitation program | conventional rehabilitation Receives: Behavioral: Fast rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pinch strength
standard hydraulic hand dynamometer
Measured: 6 weeks
Secondary outcomes (1)
range of motion
range of hand motion
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study startFeb 2014
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: No resident involvement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. David Pichora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. David Pichora, Queen's University
- Investigators
- David Pichora, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571241
- Sponsor's protocol ID
- SURG-288-14
- Status last verified
- Oct 2022
- First submitted
- 24 Apr 2014
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated vs Traditional Rehabilitation Protocol Following Ligament Reconstruction Tendon Interposition Surgery Using Interference Screw Fixation for 1st CMC Arthritis .
- ClinicalTrials.gov ID
- NCT05571241
- Acronym / sponsor ID
- SURG-288-14
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No resident involvement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr. David PichoraUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fast rehabilitation program | – | Behavioral: Fast rehabilitation programconventional rehabilitation |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- rheumatoid arthritis
- gout
- cervical radiculopathy
- previous thumb/1st CMC surgery
- post-traumatic arthritis of 1st CMC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast rehabilitation program1-2 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 | Behavioural | fast rehabilitation program |
Primary outcome
Pinch strength
Time frame: 6 weeks
standard hydraulic hand dynamometer
1 secondary outcome
range of motion
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
Related trials for Osteoarthritis
Not yet recruitingPhase 2
PPV-06 Vaccine in Inflammatory Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Boosting Exercise Adherence in Knee Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 4
Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Osteoarthritis Thumb
Not yet recruiting
Tempo-controlled Low-load Resistance Training in Patients With Knee Osteoarthritis.
Knee Osteoarthritis
Recruiting
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Thumb Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pichora, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Dr. David Pichora at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pinch strength (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.