Clinical trial NCT06112145: Are Rehabilitation Results in Flexor Tendon Zone II Injuries as Bad as Feared?
Official title: Are Rehabilitation Results in Flexor Tendon Zone II Injuries as Bad as Feared?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flexor Tendon Rupture
Hand Injuries
Rehabilitation
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hand is the basic functional organ of the human body and is responsible for complex tasks such as grasping and catching. It also plays an important role in a person's daily life, self-care activities and business life. When the flexor tendon system, which is necessary for the effective use of the hand, is damaged, it can cause physical, socioeconomic deterioration, mood disorders and permanent disabilities in the individual. Treatment of flexor tendon injuries after appropriate surgical repair ıt includes an intensive rehabilitation program. In this study, it was aimed to investigate the early rehabilitation results of patients who underwent a rehabilitation program after Zone II flexor tendon injury by comparing the improvements in joint range of motion, pain, functionality and quality of life with other zone injuries.

Detailed description: Tendon cuts constitute a significant portion of hand injuries. Today, most flexor tendon ruptures are repaired the same day as the injury or a few days later. Rehabilitation after flexor tendon repair is at least as important as surgical repair. Hand rehabilitation protocol after tendon repair; It consists of four periods: 1-4 weeks early period, 4-6 weeks early intermediate period, 6-8 weeks intermediate period, 8-12 weeks late period. Modified Duran Protocol is one of the earliest passive mobilization methods. According to this protocol, it has been reported that 3-5 mm of passive movement of the tendon anastomosis is effective in preventing tendon adhesions. In the literature, the number of studies examining rehabilitation results in patients with flexor tendon zone II injuries is quite limited. Post-operative rehabilitation results are worse in patients with zone II tendon injuries compared to other flexor zone injuries. This study aimed to investigate the early rehabilitation results of patients who underwent a rehabilitation program after Zone II flexor tendon injury by comparing the improvements in joint range of motion, pain, functionality and quality of life with other zone injuries. 70 patients who applied to Ankara City Hospital Physical Therapy and Rehabilitation Hospital Traumatic Hand Clinic due to flexor tendon injury and met the inclusion criteria for the study will be included. Demographic characteristics of the patients (age, gender), occupation, cause of injury, injured hand, dominant hand, smoking, and injury zones will be recorded. Patients with zone II injuries Group I, Patients with other zone injuries will be divided into Group II. In this study, Modified Duran early passive mobilization protocol was used to protect the repaired tendon and reduce the risk of adhesion will be followed. The physiotherapist will advised each patient on the things to consider after the operation, orthosis use and care, and the rehabilitation process. Early passive mobilization exercises in the form of passive flexion and extension and edema massage will be taught to all fingers of the injured hand in a dorsal blocking orthosis and will be recommended to be applied every two hours during the day. Patient follow-up will last four weeks and afterwards, measurements will be repeated.

Eligibility criteria: Inclusion Criteria:

* Had a traumatic flexor tendon injury
* In the acute period after repair (1-4 weeks)

Exclusion Criteria:

* Accompanying fracture, dislocation, burn
* infection, malignancy
* Patients using steroid-nonsteroidal drugs and having cognitive dysfunction

Primary outcomes:
measure: Visual Analog Scale
timeFrame: baseline and 4th week
measure: Range of motion
timeFrame: baseline and 4th week
Secondary outcomes:
measure: Duruoz Hand Index
timeFrame: baseline and 4th week
measure: Short Form-36
timeFrame: baseline and 4th week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Kırşehir Ahi Evran University, Kırşehir/TURKEY
name: Nazife K KAPAN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara City Hospital, Ankara/TURKEY
name: Merve K KAPAN, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara City Hospital, Ankara/TURKEY
name: Berat Meryem A ALKAN, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Ankara City Hospital, Ankara/TURKEY
name: Bedriye B BAŞKAN, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Health Sciences Univercity, Gülhane faculty of physiotherapy and rehabilitation, Ankara/TURKEY
name: Tezel YŞ YILDIRIM ŞAHAN, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: Stenekes MW, Geertzen JH, Nicolai JP, De Jong BM, Mulder T. Effects of motor imagery on hand function during immobilization after flexor tendon repair. Arch Phys Med Rehabil. 2009 Apr;90(4):553-9. doi: 10.1016/j.apmr.2008.10.029.
citation: Kannas S, Jeardeau TA, Bishop AT. Rehabilitation following zone II flexor tendon repairs. Tech Hand Up Extrem Surg. 2015 Mar;19(1):2-10. doi: 10.1097/BTH.0000000000000076.
citation: 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.
citation: Cetin A, Dincer F, Kecik A, Cetin M. Rehabilitation of flexor tendon injuries by use of a combined regimen of modified Kleinert and modified Duran techniques. Am J Phys Med Rehabil. 2001 Oct;80(10):721-8. doi: 10.1097/00002060-200110000-00003.