Volar Plate Injury, Thumb, Metacarpophalangeal JointPhase 1MJRUVCBGNCT01467752
Metacarpophalangeal Joint Reconstruction Using a Vascularized Cartilage and Bone Graft
A Phase 1 study testing MCP joint in people with Volar Plate Injury, Thumb, Metacarpophalangeal Joint, run by The Second Hospital of Qinhuangdao at 1 site in China.
Trial summary
Traumatic cartilage loss of the joint is central to the development of joint failure in arthritis. The study on the use of a bone graft for reconstruction of metacarpophalangeal joint defects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Volar Plate Injury, Thumb, Metacarpophalangeal Joint
- What is being tested?
- MCP joint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Jan 2005to Dec 2009
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a cartilage defect at either proximal or distal MCP joint;
- either an acute or old injury;
- loss of 1/4 of joint entire surface that seen on plain radiographs, CT scan, and intraoperative finding;
- and with or without MCP joint subluxation.
Who cannot join
- large defects involved double joint surfaces;
- the size of the defect involving less than 1/4 of the joint surface;
- associate with infection or other diseases that restrict to use the technique.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study for Reconstruction of Metacarpophalangeal Joint Using a Vascularized Cartilage and Bone Graft From the Third Metacarpal
Traumatic cartilage loss of the joint is central to the development of joint failure in arthritis. The study on the use of a bone graft for reconstruction of metacarpophalangeal joint defects.
Read the detailed description
The metacarpophalangeal joint is vital for hand function. Cartilage loss of the joint is central to the development of joint failure in arthritis. Although various treatments have been proposed, the management remains a challenging problem.Previous anatomical studies have shown that, at the base of the metacarpal, there were nutrient arteries inserting into the dorsum of the metacarpal. The nutrient arteries arise from the distal and middle dorsal carpal arches that run distally to the first to fourth dorsal metacarpal arteries (DMAs. These studies prompt us to use a reverse vascularized cartilage and bone graft based on the DMA. The metacarpal consists of a widened proximal base. The joint surface to the capitate is convex anteriorly and dorsally concave, where it extends to the styloid process on the dorsolateral aspect of the metacarpal base. The unique contour stimulates our imagination and creativity to use a portion of the joint surface for reconstruction of metacarpophalangeal joint defects. The purpose of this study is to report the novel technique and to evaluate the effectiveness of the treatment.
- Being tested
- MCP joint
- Keywords
- reconstruction, metacarpophalangeal joint, bone graft, MCP joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCP jointProcedure or surgery
Also called MCP joint reconstruction
reconstruction of metacarpophalangeal (MCP) joint using a bone graft
| Study group | Role | What they receive |
|---|---|---|
| MCP joint | Experimental | reconstruction of metacarpophalangeal (MCP) joint Receives: Procedure: MCP joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion; Arm, Shoulder and Hand questionnaire
The active motions of the hand were measured by a goniometer. The patients rated their MCP joint pain, the donor joint pain, and scar pain using a line by a visual analogue scale (VAS). We used the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire to assess the hand function.
Measured: 4 years
Secondary outcomes (1)
Pain
joint pain is assessed using visual analogue scale
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startJan 2005
- Primary completionJan 2005
- Study completionDec 2009
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 Volar Plate Injury, Thumb, Metacarpophalangeal JointStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Qinhuangdao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Zhang, The Second Hospital of Qinhuangdao
- Investigators
- Xu Zhang, MD, Study chair, The Second Hospital of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467752
- Sponsor's protocol ID
- XZhang201111
- Other IDs
- SHQ
- Acronym
- MJRUVCBG
- Status last verified
- Nov 2011
- First submitted
- 2 Nov 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sebastin SJ, Mendoza RT, Chong AKS, Peng YP, Ono S, Chung KC, Lim AYT. Application of the dorsal metacarpal artery perforator flap for resurfacing soft-tissue defects proximal to the fingertip. Plast Reconstr Surg. 2011 Sep;128(3):166e-178e. doi: 10.1097/PRS.0b013e318221ddfa.
PubMed 21865990
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study for Reconstruction of Metacarpophalangeal Joint Using a Vascularized Cartilage and Bone Graft From the Third Metacarpal
- ClinicalTrials.gov ID
- NCT01467752
- Acronym / sponsor ID
- MJRUVCBG / XZhang201111
- Keywords
- reconstruction, metacarpophalangeal joint, bone graft, MCP joint
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Second Hospital of QinhuangdaoUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2005 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Nov 2011 (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.
Traumatic cartilage loss of the joint is central to the development of joint failure in arthritis. The study on the use of a bone graft for reconstruction of metacarpophalangeal joint defects.
Detailed description
The metacarpophalangeal joint is vital for hand function. Cartilage loss of the joint is central to the development of joint failure in arthritis. Although various treatments have been proposed, the management remains a challenging problem.Previous anatomical studies have shown that, at the base of the metacarpal, there were nutrient arteries inserting into the dorsum of the metacarpal. The nutrient arteries arise from the distal and middle dorsal carpal arches that run distally to the first to fourth dorsal metacarpal arteries (DMAs. These studies prompt us to use a reverse vascularized cartilage and bone graft based on the DMA. The metacarpal consists of a widened proximal base. The joint surface to the capitate is convex anteriorly and dorsally concave, where it extends to the styloid process on the dorsolateral aspect of the metacarpal base. The unique contour stimulates our imagination and creativity to use a portion of the joint surface for reconstruction of metacarpophalangeal joint defects. The purpose of this study is to report the novel technique and to evaluate the effectiveness of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCP joint | Experimental | Procedure: MCP jointreconstruction of metacarpophalangeal (MCP) joint |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- a cartilage defect at either proximal or distal MCP joint;
- either an acute or old injury;
- loss of 1/4 of joint entire surface that seen on plain radiographs, CT scan, and intraoperative finding;
- and with or without MCP joint subluxation.
Key exclusion criteria (3 listed)
- large defects involved double joint surfaces;
- the size of the defect involving less than 1/4 of the joint surface;
- associate with infection or other diseases that restrict to use the technique.
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 |
|---|---|---|
| MCP jointAlso: MCP joint reconstructionreconstruction of metacarpophalangeal (MCP) joint using a bone graft | Procedure or surgery | MCP joint |
Primary outcome
Range of motion; Arm, Shoulder and Hand questionnaire
Time frame: 4 years
The active motions of the hand were measured by a goniometer. The patients rated their MCP joint pain, the donor joint pain, and scar pain using a line by a visual analogue scale (VAS). We used the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire to assess the hand function.
1 secondary outcome
Pain
Time frame: 4 years
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 9 Nov 2011.
- Results publication: PubMed 21865990Sebastin SJ, Mendoza RT, Chong AKS, Peng YP, Ono S, Chung KC, Lim AYT. Application of the dorsal metacarpal artery perforator flap for resurfacing soft-tissue defects proximal to the fingertip. Plast Reconstr Surg. 2011 Sep;128(3):166e-178e. doi: 10.1097/PRS.0b013e318221ddfa.
- Application of the dorsal metacarpal artery perforator flap for resurfacing soft-tissue defects proximal to the fingertipLink provided by the sponsor.
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.
Xu Zhang, MD study chair
The Second Hospital of Qinhuangdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MCP joint in people with Volar Plate Injury, Thumb, Metacarpophalangeal Joint, run by The Second Hospital of Qinhuangdao at 1 site in China.
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 3 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 9 Nov 2011. 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 China. 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 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.
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?
Range of motion; Arm, Shoulder and Hand questionnaire (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01467752, 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 9 Nov 2011.