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Tendon Injury - HandNCT04962490

Study of the Repair of Flexor Tendons of the Hand

An observational study of Tendon Injury - Hand, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Injury to the flexor tendons of the fingers of the hand is a frequent and disabling injury, since it produces tendon retraction and functional limitation. A prompt and adequate diagnosis and treatment is required to minimize the risk of tendon retraction, re-rupture, reoperation rate, and the presence of tendon… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Tendon Injury - Hand
What is being tested?
Repair: suture, reinsertion, tendon graft, surgery in two stages (Hunter, Paneva Holevich)
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteSpain
Study dates
23 Jul 2021to 16 Dec 2024
Phase
Observational
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 85 years
  • All sexes
  • Adult, Older adult

Study population: All patients between 18 and 85 years of age who have suffered a hand injury with section / s of the superficial and / or profundus flexor tendons, or both in hand; and flexor tendon in the thumb.

Who may be able to join

  • Patients with section of the superficial and / or profundus flexor tendons in the hand.
  • Patients with section of the flexor tendon in the thumb
  • Tendon injury in any anatomical area
  • In the acute, subacute or chronic phases of the disease
  • Associated or not with fractures
  • Associated or not with arterial or nerve injuries

Who cannot join

  • Previous bone disease
  • History of tendon injury to the extensor or flexor tendons
  • Joint stiffness prior to tendon section
  • Rheumatic arthropathy
  • History of operations in the same area.

Trial locations and contacts

1 site in 1 country.

Claudia Lamas, MD. Ph D contact

935537032

clamasg@santpau.cat

Claudia Lamas, MD, Ph D contact

935537032

clamasg@santpau.cat

Spain1 site, 1 recruiting

  • Claudia Erika Delgado Espinoza

    Barcelona, 08025

    Claudia Erika Delgado Espinoza, MD, Ph D, 935537634, CDelgadoE@santpau.cat

    Claudia Erika Delgado Espinoza, MD, Ph D, CDelgadoE@santpau.cat

    Recruiting

Other trials in Spain

About this study

Official title: Study of the Repair of Flexor Tendons of the Hand: Epidemiological and Prognostic Factors Associated With Tendon Injuries in Zone II

Injury to the flexor tendons of the fingers of the hand is a frequent and disabling injury, since it produces tendon retraction and functional limitation. A prompt and adequate diagnosis and treatment is required to minimize the risk of tendon retraction, re-rupture, reoperation rate, and the presence of tendon adhesions that limit the range of motion. On occasions, the limitation of the articular balance of the MCP, PIP and DIP joints generates a loss of strength and difficult in completely closing the fingers to the palm of the hand.

Read the detailed description

To retrospectively evaluate the results obtained with the suture/ reinsertion of the flexor tendons of the hand, in the acute, subacute and chronic phases, treated surgically in our center between the years 2000 and 2021.

To evaluate the clinical and functional results obtained in patients who underwent surgery for a section of the flexor tendons, superficial, profundus or both, preferably in zone II of the hand. The investigators evaluate the epidemiological and prognostic factors associated with the injury, in the different phases and anatomical zones.

The researchers evaluate the functional results:

Pain at rest with movements: Assessed using the visual analogue pain scale (VAS Scale from 0 to 10).

Joint balance / Range of motion of the MCP, PIP, DIP joints. Evaluation by digital goniometer. Evaluation using Buck-Gramcko (1976) and using the Tang (2007) criteria.

Grip strength. Evaluation using a Jamar dynamometer. Functional rating scales: QuickDASH Score Reoperation rate: 1) For re-rupture / re-suture, 2) For infection, 3) For excision of tendon adhesions: arthrolysis and tendolysis, 4) For tendon transfer 5) For tendon graft placement.

Being tested
Repair: suture, reinsertion, tendon graft, surgery in two stages (Hunter, Paneva Holevich)
Keywords
tendon, flexor, hand

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repair: suture, reinsertion, tendon graft, surgery in two stages (Hunter, Paneva Holevich)Procedure or surgery

    Repair tendon flexor sections in the hand: Suture, reinsertion, tendon graft, surgery in two stages (Hunter, Paneva Holevich). The surgery depends on the anatomical area of the tendon section and the time between the injury and the operation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Range of motion (ROM)

    Change in the mobility of the MCP, PIP and DIP joints. Evaluation with goniometer (cm)

    Measured: 12 months

  2. Grip Strength

    Change of strength with respect to the contralateral hand. Evaluation with Jamar Dinamometer (Kg)

    Measured: 12 months

  3. Chronic residual pain

    Evaluation residual pain at rest and with activity with the Visual Analogue Scale (values from 0 to 10; 0 is the better outcome and 10 is the worse outcome).

    Measured: 12 months

Secondary outcomes (2)

  1. Epidemiological variables age, sex, smoker, diabetes, heart disease, other diseases (lung, kidney, etc.).

    Evaluacion of epidemiological factors associated with outcomes in flexor injuries.

    Measured: 12 months

  2. Trauma variables

    Affected finger, dominant hand, involvement of one or more fingers, type of injury (complete / partial section / association with fractures /association with arterial injury/ association with nerve injury/ section only FP or section FS plus FP).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2021
  2. Study start23 Jul 2021
  3. Primary completion15 Jul 2024 (estimated)
  4. Study completion16 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04962490
Sponsor's protocol ID
IIBSP-TFM-2021-34
Status last verified
Mar 2023
First submitted
5 Jul 2021
Last updated
21 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Doyle JR. Anatomy of the flexor tendon sheath and pulley system: a current review. J Hand Surg Am. 1989 Mar;14(2 Pt 2):349-51. doi: 10.1016/0363-5023(89)90110-x.

    PubMed 2732428

  • Manske PR. Flexor tendon healing. J Hand Surg Br. 1988 Aug;13(3):237-45. doi: 10.1016/0266-7681_88_90077-0.

    PubMed 3049854

  • Tang JB. Indications, methods, postoperative motion and outcome evaluation of primary flexor tendon repairs in Zone 2. J Hand Surg Eur Vol. 2007 Apr;32(2):118-29. doi: 10.1016/J.JHSB.2006.12.009. Epub 2007 Feb 12.

    PubMed 17298858

  • Tang JB. Flexor tendon repair in zone 2C. J Hand Surg Br. 1994 Feb;19(1):72-5. doi: 10.1016/0266-7681(94)90054-x.

    PubMed 8169485

  • Moriya K, Yoshizu T, Tsubokawa N, Narisawa H, Matsuzawa S, Maki Y. Outcomes of flexor tendon repairs in zone 2 subzones with early active mobilization. J Hand Surg Eur Vol. 2017 Nov;42(9):896-902. doi: 10.1177/1753193417715213. Epub 2017 Jun 13.

    PubMed 28610452

  • Amadio PC, Hunter JM, Jaeger SH, Wehbe MA, Schneider LH. The effect of vincular injury on the results of flexor tendon surgery in zone 2. J Hand Surg Am. 1985 Sep;10(5):626-32. doi: 10.1016/s0363-5023(85)80197-0.

    PubMed 4045137

  • Lundborg G, Myrhage R, Rydevik B. The vascularization of human flexor tendons within the digital synovial sheath region--structureal and functional aspects. J Hand Surg Am. 1977 Nov;2(6):417-27. doi: 10.1016/s0363-5023(77)80022-1.

    PubMed 925330

  • Buck-Gramcko D, Dietrich FE, Gogge S. [Evaluation criteria in follow-up studies of flexor tendon therapy]. Handchirurgie. 1976;8(2):65-9. German.

    PubMed 992488

  • Tang JB. Outcomes and evaluation of flexor tendon repair. Hand Clin. 2013 May;29(2):251-9. doi: 10.1016/j.hcl.2013.02.007.

    PubMed 23660061

  • Strickland JW. Development of flexor tendon surgery: twenty-five years of progress. J Hand Surg Am. 2000 Mar;25(2):214-35. doi: 10.1053/jhsu.2000.jhsu25a0214. No abstract available.

    PubMed 10722813

Questions about this trial

What is this clinical trial studying?

An observational study of Tendon Injury - Hand, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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 Spain. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Claudia Lamas, MD. Ph D (935537032, clamasg@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Range of motion (ROM) (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT04962490, which also lists 10 linked publications.

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 21 Mar 2024.

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