A clinical trial to compare the outcome of two different repair techniques in patients with flexor tendon injuries in their hand

Comparison of outcome of 1- and 2-knot, 4-strand, double-modified Kessler flexor tendon repair with early active mobilization protocol in patients with flexor tendon lacerations of hand

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001109897

Enrollment

100

Registered

2012-10-17

Start date

2012-10-20

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The objective of the study is to compare the outcome of flexor tendon repair techniques in term of total active motion between two groups. Flexor tendon repair will be done by consultant using 4 strands of double modified Kessler grasping core suture 4-0 polypropylene suture material with 1 knot(Group A) or 2 knot (Group B) placed between tendon ends. Both groups will undergo early active mobilization protocol starting from first post operative day. All patients will be clinically assessed in term of total active motion 3, 6 and 8 weeks postoperatively and a final assessment performed at 12 weeks postoperatively by the researcher and data will be entered in the proforma.

Interventions

It is comparison of two different surgical techniques for flexor tendon repair. 1knot technique(Group A) or 2 knot technique(Group B) with approximate duration of 60-120 min in both techniques. Early active mobilization of affected digits will be started from 1st postoperative day in both groups.Patients will follow this rehabilitation protocol for 8 weeks ,with change of exercises will be told to patients on followups.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

5 Years to 70 Years

Healthy volunteers

Inclusion criteria

Age 5 to 70 years Gender both males and females Flexor tendon lacerations of hand (on clinical examination)

Exclusion criteria

Associated extensor tendon lacerations of hand (on clinical examination) Associated fractures of hand (on X rays of affected hand) Replantation and revascularization cases of hands (on clinical examination)

Outcome results