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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 28, 2014