Claw ToeNCT01725893
Percutaneous Tenotomy of the Toe Flexor Tendon is a Simple and Efficient Method in Treating Checkrein Deformity
An observational study of Claw Toe, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Checkrein deformity represents a dynamic claw toe deformity. Surgical intervention is the treatment of choice and many methods have been proposed. The purpose of this study is to evaluate the outcomes and complications of percutaneous segmental tenotomy of the toe flexor tendons. Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Claw Toe
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2012to Mar 2013
- 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 18 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There were fourteen patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010.
Who may be able to join
- Patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010.
Who cannot join
- Patients who had static or rigid claw toe deformity
- Patients who had claw toe deformity secondary to neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Jin-Tzer Ho, M.D, 886 2 23123456 ext. 62515, herginger@gmail.com
Pei-Yu Chen, M.D
About this study
Checkrein deformity represents a dynamic claw toe deformity. Surgical intervention is the treatment of choice and many methods have been proposed. The purpose of this study is to evaluate the outcomes and complications of percutaneous segmental tenotomy of the toe flexor tendons.
Read the detailed description
The investigators reviewed fourteen patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010. Five patients received FHL and flexor digitorum longus (FDL) tenolysis at the musculotendinous junction; among them, two also underwent Z-plasty lengthening of the FHL tendon. Nine patients underwent percutaneous segmental toe flexor tenotomy. The Hallux Metatarsophalangeal- Interphalangeal Scale (Hallux MTP-IP scale) and Foot and Ankle Outcome Score (FAOS), English version LK1.0 self-explanatory questionnaire were used to evaluate the functional outcomes.
- Conditions
- Claw Toe
- Keywords
- Claw Toe
- Medical subject headings
- Hammer Toe Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Claw ToeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Hong-Nerng Ho, Professor, Study chair, National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725893
- Sponsor's protocol ID
- 201202038RIC
- Status last verified
- Nov 2012
- First submitted
- 25 Sep 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee HS, Kim JS, Park SS, Lee DH, Park JM, Wapner KL. Treatment of checkrein deformity of the hallux. J Bone Joint Surg Br. 2008 Aug;90(8):1055-8. doi: 10.1302/0301-620X.90B8.20563.
PubMed 18669962
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tenotomy of the Toe Flexor Tendon is a Simple and Efficient Method in Treating Checkrein Deformity
- ClinicalTrials.gov ID
- NCT01725893
- Acronym / sponsor ID
- 201202038RIC
- Conditions
- Claw Toe
- Keywords
- Claw Toe
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 14 Nov 2012 (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.
Checkrein deformity represents a dynamic claw toe deformity. Surgical intervention is the treatment of choice and many methods have been proposed. The purpose of this study is to evaluate the outcomes and complications of percutaneous segmental tenotomy of the toe flexor tendons.
Detailed description
The investigators reviewed fourteen patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010. Five patients received FHL and flexor digitorum longus (FDL) tenolysis at the musculotendinous junction; among them, two also underwent Z-plasty lengthening of the FHL tendon. Nine patients underwent percutaneous segmental toe flexor tenotomy. The Hallux Metatarsophalangeal- Interphalangeal Scale (Hallux MTP-IP scale) and Foot and Ankle Outcome Score (FAOS), English version LK1.0 self-explanatory questionnaire were used to evaluate the functional outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There were fourteen patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010.
Key inclusion criteria (1 listed)
- Patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010.
Key exclusion criteria (2 listed)
- Patients who had static or rigid claw toe deformity
- Patients who had claw toe deformity secondary to neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- Results publication: PubMed 18669962Lee HS, Kim JS, Park SS, Lee DH, Park JM, Wapner KL. Treatment of checkrein deformity of the hallux. J Bone Joint Surg Br. 2008 Aug;90(8):1055-8. doi: 10.1302/0301-620X.90B8.20563.
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.
Hong-Nerng Ho, Professor study chair
National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)
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 Claw Toe, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 14 Nov 2012. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Tzer Ho, M.D (886 2 23123456 ext. 62515, herginger@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01725893, which also lists 1 linked publication.
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 14 Nov 2012.