Adhesion of Flexor Tendon of HandPhase 1/2NCT00261209
Collagenase in the Treatment of Zone II Flexor Tendon Adhesions in the Hand
A Phase 1/2 study testing Collagenase and Collagenase injection in people with Adhesion of Flexor Tendon of Hand, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of this study is to dissolve flexor tendon adhesions associated with failed tendon repair surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adhesion of Flexor Tendon of Hand
- What is being tested?
- Collagenase and Collagenase injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2008
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- zone II flexor tendon adhesion of at least one finger
Who cannot join
- any chronic, serious or uncontrolled medical condition
- inability to conform to study visits (12-15 per year)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept. Orthopaedics, SUNY@Stony Brook
Stony Brook, New York, 11794
About this study
Official title: Study of Collagenase Injection Therapy for Treatment of Zone II Flexor Tendon Adhesions in the Hand
The purpose of this study is to dissolve flexor tendon adhesions associated with failed tendon repair surgery.
Read the detailed description
In an open label study, collagenase injection therapy was investigated in 3 subjects for it's ability to lyse flexor tendon adhesions in zone II of the hand.
Results indicate that two of three subjects had improved range of finger motion at the PIP and DIP joints. This may obviate the need for patients to have tenolysis hand surgery to correct the finger flexion contracture of the PIP and DIP joints. Detailed controlled studies remain to be done.
- Conditions
- Adhesion of Flexor Tendon of Hand
- Being tested
- Collagenase, Collagenase injection
- Keywords
- Flexor Tendon Adhesions, Zone II of the Hand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CollagenaseDrug
Also called Collagenase Clostridium Histolyticum
Collagenase injection into adhesion restricting tendon gliding
Collagenase injectionDrug
Also called Collagenase Clostridium Histolyticum
injection of collagenase into adhesion restricting tendon gliding
| Study group | Role | What they receive |
|---|---|---|
| Collagenase Injection | Experimental | Injection of collagenase into adhesion restricting tendon gliding Receives: Drug: Collagenase; Drug: Collagenase injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of PIP and DIP joint motion.
Measured: 6 months
Secondary outcomes (1)
Hand Grip strength (kg)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesion of Flexor Tendon of HandStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie A. Badalamente, Stony Brook University
- Investigators
- Marie A Badalamente, PhD, Principal investigator, Dept. Orthopaedics, SUNY@Stony Brook, NY 11794Edward Wang, MD, Principal investigator, Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261209
- Sponsor's protocol ID
- Tendon 101
- Status last verified
- Apr 2016
- First submitted
- 30 Nov 2005
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Collagenase Injection Therapy for Treatment of Zone II Flexor Tendon Adhesions in the Hand
- ClinicalTrials.gov ID
- NCT00261209
- Acronym / sponsor ID
- Tendon 101
- Conditions
- Adhesion of Flexor Tendon of Hand
- Keywords
- Flexor Tendon Adhesions, Zone II of the Hand
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 2 Dec 2005 (estimated)
- 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 purpose of this study is to dissolve flexor tendon adhesions associated with failed tendon repair surgery.
Detailed description
In an open label study, collagenase injection therapy was investigated in 3 subjects for it's ability to lyse flexor tendon adhesions in zone II of the hand.
Results indicate that two of three subjects had improved range of finger motion at the PIP and DIP joints. This may obviate the need for patients to have tenolysis hand surgery to correct the finger flexion contracture of the PIP and DIP joints. Detailed controlled studies remain to be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collagenase Injection | Experimental | Drug: Collagenase, Drug: Collagenase injectionInjection of collagenase into adhesion restricting tendon gliding |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- zone II flexor tendon adhesion of at least one finger
Key exclusion criteria (2 listed)
- any chronic, serious or uncontrolled medical condition
- inability to conform to study visits (12-15 per year)
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 |
|---|---|---|
| CollagenaseAlso: Collagenase Clostridium HistolyticumCollagenase injection into adhesion restricting tendon gliding | Drug | Collagenase Injection |
| Collagenase injectionAlso: Collagenase Clostridium Histolyticuminjection of collagenase into adhesion restricting tendon gliding | Drug | Collagenase Injection |
Primary outcome
Restoration of PIP and DIP joint motion.
Time frame: 6 months
1 secondary outcome
Hand Grip strength (kg)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Adhesion of Flexor Tendon of Hand
Recruiting
Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair
Tendon Adhesion, Zone II Flexor Tendon Injury
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.
Marie A Badalamente, PhD principal investigator
Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
Edward Wang, MD principal investigator
Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Collagenase and Collagenase injection in people with Adhesion of Flexor Tendon of Hand, run by Stony Brook University at 1 site in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 21 Apr 2016. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Restoration of PIP and DIP joint motion. (time frame: 6 months). 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 21 Apr 2016.