Recurrent Dislocation of HandPIPPCNCT01479738
Proximal Interphalangeal Joint Arthroplasty Using a Graft From the Capitate
A study testing Capitate bone grafting in people with Recurrent Dislocation of Hand, run by The Second Hospital of Qinhuangdao at 1 site in China.
Trial summary
The capitate had a widened distal base. The distal articulation can be used for proximal interphalangeal (PIP) articula reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Recurrent Dislocation of Hand
- What is being tested?
- Capitate bone grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Jan 2005to Oct 2011
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- an articular defect at the proximal aspect of the PIP joint;
- the defect larger than 5 mm × 5 mm in size based on intraoperative findings.
Who cannot join
- large defects involved double joint surfaces;
- the size of the defect less than 5 mm × 5 mm;
- mult-digital articular defects that all required osteoarticular grafting;
- 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: The Second Hospital of Qinhuangdao, Qinhuangdao, Hebei, 066600, China
The capitate had a widened distal base. The distal articulation can be used for proximal interphalangeal (PIP) articula reconstruction.
Read the detailed description
Previous anatomical studies have shown that the capitate had a widened distal base. The distal articulation was mainly with the base of the third metacarpal and partially with the base of the second metacarpal. The articulation was slightly flattened with a convex and concave dorsal articular surface. The contour stimulates our imagination and creativity to use a portion of the articular surface for PIP arthroplasty.
- Conditions
- Recurrent Dislocation of Hand
- Being tested
- Capitate bone grafting
- Keywords
- arthroplasty, graft, capitate, artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capitate bone graftingProcedure or surgery
Capitate bone graft transfer for PIP joint reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Capitate bone grafting | Experimental | 18 patients with PIP joint defects were included in the study. There were 13 male and 5 female patients with a mean age of 31 years (range, 18-47 years). The injury occurred in the right hand in 11 patients and on the left hand in 7. The injured PIP joints were in the index finger (n=7), long finger (n=9), and ring finger (n=2). Receives: Procedure: Capitate bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
Active range of motion of the hand were measured by a goniometer.
Measured: 37 to 46 months postoperatively
Secondary outcomes (2)
grip strength
The grip strength of the thumb to the injured finger was measured using dynamometers
Measured: 37 to 46 months postoperatively
pinch strength
The pinch strength of the thumb to the injured finger was measured using dynamometers
Measured: 37 to 46 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startJan 2005
- Primary completionAug 2011
- Study completionOct 2011
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 Recurrent Dislocation 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Qinhuangdao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu Zhang, M.D., Study chair, The Second Hospital of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479738
- Sponsor's protocol ID
- SHQ002
- Acronym
- PIPPC
- Status last verified
- Nov 2011
- First submitted
- 19 Nov 2011
- Last updated
- 28 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Freiberg A. Management of proximal interphalangeal joint injuries. Can J Plast Surg. 2007 Winter;15(4):199-203. doi: 10.1177/229255030701500407.
PubMed 19554177
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Hospital of Qinhuangdao, Qinhuangdao, Hebei, 066600, China
- ClinicalTrials.gov ID
- NCT01479738
- Acronym / sponsor ID
- PIPPC / SHQ002
- Conditions
- Recurrent Dislocation of Hand
- Keywords
- arthroplasty, graft, capitate, artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Second Hospital of QinhuangdaoUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 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.
The capitate had a widened distal base. The distal articulation can be used for proximal interphalangeal (PIP) articula reconstruction.
Detailed description
Previous anatomical studies have shown that the capitate had a widened distal base. The distal articulation was mainly with the base of the third metacarpal and partially with the base of the second metacarpal. The articulation was slightly flattened with a convex and concave dorsal articular surface. The contour stimulates our imagination and creativity to use a portion of the articular surface for PIP arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capitate bone grafting | Experimental | Procedure: Capitate bone grafting18 patients with PIP joint defects were included in the study. There were 13 male and 5 female patients with a mean age of 31 years (range, 18-47 years). The injury occurred in the right hand in 11 patients and on the left hand in 7. The injured PIP joints were in the index finger (n=7), long finger (n=9), and ring finger (n=2). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- an articular defect at the proximal aspect of the PIP joint;
- the defect larger than 5 mm × 5 mm in size based on intraoperative findings.
Key exclusion criteria (4 listed)
- large defects involved double joint surfaces;
- the size of the defect less than 5 mm × 5 mm;
- mult-digital articular defects that all required osteoarticular grafting;
- 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 |
|---|---|---|
| Capitate bone graftingCapitate bone graft transfer for PIP joint reconstruction | Procedure or surgery | Capitate bone grafting |
Primary outcome
range of motion
Time frame: 37 to 46 months postoperatively
Active range of motion of the hand were measured by a goniometer.
2 secondary outcomes
grip strength
Time frame: 37 to 46 months postoperatively
pinch strength
Time frame: 37 to 46 months postoperatively
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 28 Nov 2011.
- Background: PubMed 19554177Freiberg A. Management of proximal interphalangeal joint injuries. Can J Plast Surg. 2007 Winter;15(4):199-203. doi: 10.1177/229255030701500407.
- Management of proximal interphalangeal joint injuriesLink 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, M.D. 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 study testing Capitate bone grafting in people with Recurrent Dislocation of Hand, 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 2 inclusion and 4 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 28 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.
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 (time frame: 37 to 46 months postoperatively). 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 NCT01479738, 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 28 Nov 2011.