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Proximal Interphalangeal Joint Arthroplasty Using a Graft From the Capitate (PIPPC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Qinhuangdao
ClinicalTrials.gov Identifier:
NCT01479738
First received: November 19, 2011
Last updated: November 24, 2011
Last verified: November 2011
History of Changes
  Purpose

The capitate had a widened distal base. The distal articulation can be used for proximal interphalangeal (PIP) articula reconstruction.


Condition Intervention
Recurrent Dislocation of Hand
 Procedure: Capitate bone grafting

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Second Hospital of Qinhuangdao, Qinhuangdao, Hebei, 066600, China

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Second Hospital of Qinhuangdao:

Primary Outcome Measures:
  • range of motion [ Time Frame: 37 to 46 months postoperatively ] [ Designated as safety issue: Yes ]
    Active range of motion of the hand were measured by a goniometer.


Secondary Outcome Measures:
  • grip strength [ Time Frame: 37 to 46 months postoperatively ] [ Designated as safety issue: Yes ]
    The grip strength of the thumb to the injured finger was measured using dynamometers

  • pinch strength [ Time Frame: 37 to 46 months postoperatively ] [ Designated as safety issue: Yes ]
    The pinch strength of the thumb to the injured finger was measured using dynamometers


Enrollment: 18
Study Start Date: January 2005
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capitate bone grafting
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).
 Procedure: Capitate bone grafting
Capitate bone graft transfer for PIP joint 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. an articular defect at the proximal aspect of the PIP joint;
  2. the defect larger than 5 mm × 5 mm in size based on intraoperative findings.

Exclusion Criteria:

  1. large defects involved double joint surfaces;
  2. the size of the defect less than 5 mm × 5 mm;
  3. mult-digital articular defects that all required osteoarticular grafting;
  4. associate with infection or other diseases that restrict to use the technique.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479738

Locations
China, Hebei
The second hospital of Qinhuangdao
Qinhuangdao, Hebei, China, 066600
Sponsors and Collaborators
The Second Hospital of Qinhuangdao
Investigators
Study Chair: Xu Zhang, M.D. The Second Hospital of Qinhuangdao
  More Information

Additional Information:
Management of proximal interphalangeal joint injuries  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: The Second Hospital of Qinhuangdao
ClinicalTrials.gov Identifier: NCT01479738     History of Changes
Other Study ID Numbers: SHQ002
Study First Received: November 19, 2011
Last Updated: November 24, 2011
Health Authority: China: Ethics Committee

Keywords provided by The Second Hospital of Qinhuangdao:
arthroplasty
graft
capitate
artery

Additional relevant MeSH terms:
Dislocations
Recurrence
Wounds and Injuries
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013