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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01479738
Other study ID # SHQ002
Secondary ID
Status Completed
Phase N/A
First received November 19, 2011
Last updated November 24, 2011
Start date January 2005
Est. completion date October 2011

Study information

Verified date November 2011
Source The Second Hospital of Qinhuangdao
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date October 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Capitate bone grafting
Capitate bone graft transfer for PIP joint reconstruction

Locations

Country Name City State
China The second hospital of Qinhuangdao Qinhuangdao Hebei

Sponsors (1)

Lead Sponsor Collaborator
The Second Hospital of Qinhuangdao

Country where clinical trial is conducted

China, 

References & Publications (1)

Freiberg A. Management of proximal interphalangeal joint injuries. Can J Plast Surg. 2007 Winter;15(4):199-203. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary range of motion Active range of motion of the hand were measured by a goniometer. 37 to 46 months postoperatively Yes
Secondary grip strength The grip strength of the thumb to the injured finger was measured using dynamometers 37 to 46 months postoperatively Yes
Secondary pinch strength The pinch strength of the thumb to the injured finger was measured using dynamometers 37 to 46 months postoperatively Yes