Passive Mobilization With Place and Hold vs Active Mobilization Therapy After Flexor Tendon Repair

NCT04385485 | Completed

• 1 other identifier: 1001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate if active mobilisation after flexor tendon repair in fingers gives better range of motion, strength, risk of rupture and patient satisfaction compared with passive mobilisation with place and hold after flexor tenon repair.

Conditions

Tendon Injury - Hand

Keywords

Flexor tendon injury; Early Mobilisation

Outcome Measures

Primary Outcomes (1)

• Range of motion

  Range of motion in the proximal and distal interphalangeal joints in the injured finger and corresponding finger in the other hand are measured after 4, 8 and 12 weeks and after 6 and 12 months and minimum 5 years after surgery. We are interested to learn if there is a difference in range of motion between the two study groups.

  Up to minimum 5 years after surgery

Secondary Outcomes (5)

• Jamar grip strength

  Up to minimum 5 years after surgery

• Key Pinch strength

  Up to minimum 5 years after surgery

• Tendon rerupture

  Up to minimum 5 years after surgery

• Need of secondary operation

  Up to minimum 5 years after surgery

• Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure questionaire

  Up to minimum 5 years after surgery

Study Arms (2)

Active mobilisation

EXPERIMENTAL

The patient see an occupational therapist 1-3 days after surgery. A splint is made to immobilise the wrist and work as a extension block for the MCP-joints. This splint has to be worn day and night for 4 weeks. Another splint that immobilise the distal interphalangeal (DIP) joint and the proximal interphalangeal (PIP) joints are worn whenever the patient is not exercising. During active exercise the patient follows a strict protocol with both active and passive training and increasing number of repetitions. The rehabilitation is proceeding for 3 months.

Procedure: Active mobilisation

Passive mobilisation with place and hold

ACTIVE COMPARATOR

1-3 days after surgery the patient gets a new plaster that immobilise the wrist and work as an extension block for the MCP-joints. The occupational therapist attach rubberbands to the nails of all the fingers and the training is done passively with active hold according to a strict protocol. The training with rubberbands is done during 4 weeks. After that the rehabilitation is active. The rehabilitation is proceeding for 3 months.

Procedure: Passive mobilisation with place and hold

Interventions

Active mobilisation PROCEDURE

We investigate if active mobilisation is as good as passive mobilisation with place and hold after flexor tendon suture.

Active mobilisation

Passive mobilisation with place and hold PROCEDURE

We investigate if active mobilisation is as good as passive mobilisation with place and hold after flexor tendon suture.

Passive mobilisation with place and hold

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary, complete injury to FDP in digit II-V
• Injury in zone I och II
• Operation within 72 hours from injury
• The patient must be able to fulfill the rehabilitation program.

You may not qualify if:

• Concomitant fracture
• Concomitant soft tissue defect
• Severe crush injury
• Palmar plate injury demanding immobilisation
• Concomitant joint injury
• Concomitant extensor tendon injury
• Bilateral injury
• Previous loss of function in the finger before the injury
• Uncertainty if the patient can fulfill the rehabilitation
• The surgeon think it is unsuitable with active training after surgery
• Concomitant injury of the flexor digitorum superficialis (FDS) or a digital nerve is accepted. A distal injury in zone I is not included if it requires a reinsertion of the tendon to the bone.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Department of Hand Surgery, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden, Sweden

Location

Study Officials

• Jan Fridén, Professor

  Sahlgrenska University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The occupational therapist who do the evaluation and make all the measurements 6 and 12 months after surgery don't know if the patient was randomised to active or passive mobilisation. Likewise the hand surgeon who do all the measurements at minimum 5 years after surgery don't know which rehabilitation protocol the patient followed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Hand Surgery

Model Details: The Patients are randomised 1-3 days after surgery to either active or passive mobilisation. The randomisation was done by a statistical software program (Medstat) and the protocols are placed in numbered sealed envelopes.

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: May 13, 2020
• Study Start: July 14, 2014
• Primary Completion: August 30, 2018
• Study Completion: January 16, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)