Tendon Injury - HandNCT04385485
Passive Mobilization With Place and Hold vs Active Mobilization Therapy After Flexor Tendon Repair
A study testing Active mobilisation and Passive mobilisation with place and hold in people with Tendon Injury - Hand, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tendon Injury - Hand
- What is being tested?
- Active mobilisation and Passive mobilisation with place and hold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jul 2014to 16 Jan 2023
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Concomitant fracture
- Concomitant soft tissue defect
- Severe crush injury
- Palmar plate injury demanding immobilisation
- Concomitant joint injury
- Concomitant extensor tendon injury
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Hand Surgery, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
About this study
Official title: Passive Mobilization With Place and Hold Versus Active Motion Therapy After Flexor Tendon Repair: 5-year Minimum Follow-up of A Randomized Controlled Trial
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.
Read the detailed description
Patients with an injury in flexor digitorum profundus (FDP) are eligible for inclusion in this study. The patients are referred to the Department of Hand Surgery at Sahlgrenska University Hospital. Potential patients are informed about the study. An informed consent is obtained from those who accept to participate. The surgery is performed in the same way for all patients with a four-stranded core suture and an epitendinous suture. The randomisation is performed after surgery when the patient is starting up rehabilitation 1-3 days after surgery. The randomisation was done by a computer program and the two different mobilisation protocols are placed accordingly in sealed envelopes numbered from 1 to 64. The envelopes are used one after another in a consecutive order.
All the operations are done by specialists in hand surgery or experienced residents in hand surgery at the clinic. The FDP tendon is repaired with a four-stranded core suture with a 4-0 Ti-cron (nonabsorbable braided polyester) and a running epitendinous suture according to Silfverskiöld with a 6-0 Prolene (nonabsorbable monofil polypropylene). Any concomitant injury in the flexor digitorum superficialis (FDS) tendon is repaired according to the surgeons preference. Any digital nerve is repaired with microsurgical instruments and a 8-0 or 9-0 S\&T (non-absorbable polyamide monofilament).
Mobilisation
1-3 days after surgery the patient will be randomised to either active mobilisation or passive mobilisation with rubber bands and active place-and-hold at the hand rehabilitation unit in our clinic. The patients in both groups are closely followed by an occupational therapist for 12 weeks. Additional follow-up appointments are planned after 6 and 12 months. Patients in both groups are allowed to do all kinds of normal activity after 3 months and heavy manual work and gym training after 4 months.
Active mobilisation The active mobilisation program is based on the two programs, Belfast (ref) and Billericay (ref). Our program is a mix between these two. On the first day of mobilisation (1-3 days after surgery) the dressings are changed and a dorsal splint with the wrist in neutral position and the metacarpophalangeal (MCP) joints in 60-80 degrees of flexion is made for the patient. Another removable volar plate keeping the fingers extended is used in addition to the dorsal splint between training sessions.
The patient is instructed to flex the fingers passively with the other hand and then keep the fingers in flexion and do the place and hold for 3 seconds. Then the fingers are extended actively as far as the splint allows. This motion is done with 5 repetitions, 10 times per day with 1.5 hour resting period between sessions. Every second training session (i.e. every third hour) all fingers are flexed actively three times. After a week both the passive motion with place-and-hold and the true active motion is done with 10 repetitions, 10 times per day with a resting time of 1.5 hours between training sessions. Four weeks post surgery flexion and extension of the wrist is added with 10 repetitions, 4 times per day and joint-by-joint training for the injured finger with 3 repetitions 10 times per day in addition to the previous protocol.
Passive mobilisation with place-and-hold Before the mobilisation starts the patients get their dressings changed and a new dorsal forearm plaster ending at the level of the proximal interphalangeal (PIP) joints with the wrist in neutral position and a dorsal block over the proximal phalanges creating an extension block for the MCP-joints of 60-80 degrees. Rubberbands are attached to all the fingernails and a small hook is fastened to the plaster to hang the rubberbands on creating a resting position for the fingers between training sessions. A night splint with the interphalangeal joints in extension is also made to protect the fingers and keep them in full extension when the patient sleeps.
The patient is instructed to flex the fingers passively with the other hand one at a time and then keep the fingers in flexion and do a gentle squeeze, so called place-and-hold. Then the fingers are extended actively as far as the plaster allows. For four weeks the patient do this exercise with 10 repetitions, 10 times a day (7-8 repetitions on the first day) with a resting period of 1.5 hours between sessions. After four weeks the plaster is removed and replaced by a splint protecting the wrist in neutral position and the patient adds true active flexion of the fingers to the previous program with 10 repetitions 10 times per day. Six weeks post surgery the splint is removed and flexion and extension of the wrist is initiated.
- Conditions
- Tendon Injury - Hand
- Being tested
- Active mobilisation, Passive mobilisation with place and hold
- Keywords
- Flexor tendon injury, Early Mobilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active mobilisationProcedure or surgery
We investigate if active mobilisation is as good as passive mobilisation with place and hold after flexor tendon suture.
Passive mobilisation with place and holdProcedure or surgery
We investigate if active mobilisation is as good as passive mobilisation with place and hold after flexor tendon suture.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Passive mobilisation with place and hold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to minimum 5 years after surgery
Secondary outcomes (5)
Jamar grip strength
Grip strength is measured with a Jamar hydraulic hand dynamometer at 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.
Measured: Up to minimum 5 years after surgery
Key Pinch strength
Key pinch strength is measured with a hydraulic pinch gauge dynamometer at 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.
Measured: Up to minimum 5 years after surgery
Tendon rerupture
We record any reruptures continuously during the study period. If there are 3 consecutive reruptures in the active group the study is terminated immediately.
Measured: Up to minimum 5 years after surgery
Need of secondary operation
At 6 and 12 months and minimum 5 years the need for secondary surgery is evaluated
Measured: Up to minimum 5 years after surgery
Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure questionaire
DASH is an outcome questionnaire with 30 questions about functions and symptoms in the upper extremity, answered by the patient. Scores range from 0 (no disability) to 100 (completely disabled). The patients are given the DASH questionaries to fill in before surgery as a baseline and again after 3, 6 and 12 months and minimum 5 years.
Measured: Up to minimum 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start14 Jul 2014
- Primary completion30 Aug 2018
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tendon Injury - HandStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Chevalley, Sahlgrenska University Hospital
- Investigators
- Jan Fridén, Professor, Study director, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385485
- Sponsor's protocol ID
- 1001
- Status last verified
- Jan 2024
- First submitted
- 4 Jul 2017
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dahlgren A, Chevalley S, Stromberg J, Bjorkman A. Item-level reanalysis of DASH outcomes after flexor tendon repair using Svensson's non-parametric method. BMC Musculoskelet Disord. 2026 Feb 27;27(1):292. doi: 10.1186/s12891-026-09626-y.
PubMed 41761199
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Mobilization With Place and Hold Versus Active Motion Therapy After Flexor Tendon Repair: 5-year Minimum Follow-up of A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04385485
- Acronym / sponsor ID
- 1001
- Conditions
- Tendon Injury - Hand
- Keywords
- Flexor tendon injury, Early Mobilisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 14 Jul 2014 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with an injury in flexor digitorum profundus (FDP) are eligible for inclusion in this study. The patients are referred to the Department of Hand Surgery at Sahlgrenska University Hospital. Potential patients are informed about the study. An informed consent is obtained from those who accept to participate. The surgery is performed in the same way for all patients with a four-stranded core suture and an epitendinous suture. The randomisation is performed after surgery when the patient is starting up rehabilitation 1-3 days after surgery. The randomisation was done by a computer program and the two different mobilisation protocols are placed accordingly in sealed envelopes numbered from 1 to 64. The envelopes are used one after another in a consecutive order.
All the operations are done by specialists in hand surgery or experienced residents in hand surgery at the clinic. The FDP tendon is repaired with a four-stranded core suture with a 4-0 Ti-cron (nonabsorbable braided polyester) and a running epitendinous suture according to Silfverskiöld with a 6-0 Prolene (nonabsorbable monofil polypropylene). Any concomitant injury in the flexor digitorum superficialis (FDS) tendon is repaired according to the surgeons preference. Any digital nerve is repaired with microsurgical instruments and a 8-0 or 9-0 S\&T (non-absorbable polyamide monofilament).
Mobilisation
1-3 days after surgery the patient will be randomised to either active mobilisation or passive mobilisation with rubber bands and active place-and-hold at the hand rehabilitation unit in our clinic. The patients in both groups are closely followed by an occupational therapist for 12 weeks. Additional follow-up appointments are planned after 6 and 12 months. Patients in both groups are allowed to do all kinds of normal activity after 3 months and heavy manual work and gym training after 4 months.
Active mobilisation The active mobilisation program is based on the two programs, Belfast (ref) and Billericay (ref). Our program is a mix between these two. On the first day of mobilisation (1-3 days after surgery) the dressings are changed and a dorsal splint with the wrist in neutral position and the metacarpophalangeal (MCP) joints in 60-80 degrees of flexion is made for the patient. Another removable volar plate keeping the fingers extended is used in addition to the dorsal splint between training sessions.
The patient is instructed to flex the fingers passively with the other hand and then keep the fingers in flexion and do the place and hold for 3 seconds. Then the fingers are extended actively as far as the splint allows. This motion is done with 5 repetitions, 10 times per day with 1.5 hour resting period between sessions. Every second training session (i.e. every third hour) all fingers are flexed actively three times. After a week both the passive motion with place-and-hold and the true active motion is done with 10 repetitions, 10 times per day with a resting time of 1.5 hours between training sessions. Four weeks post surgery flexion and extension of the wrist is added with 10 repetitions, 4 times per day and joint-by-joint training for the injured finger with 3 repetitions 10 times per day in addition to the previous protocol.
Passive mobilisation with place-and-hold Before the mobilisation starts the patients get their dressings changed and a new dorsal forearm plaster ending at the level of the proximal interphalangeal (PIP) joints with the wrist in neutral position and a dorsal block over the proximal phalanges creating an extension block for the MCP-joints of 60-80 degrees. Rubberbands are attached to all the fingernails and a small hook is fastened to the plaster to hang the rubberbands on creating a resting position for the fingers between training sessions. A night splint with the interphalangeal joints in extension is also made to protect the fingers and keep them in full extension when the patient sleeps.
The patient is instructed to flex the fingers passively with the other hand one at a time and then keep the fingers in flexion and do a gentle squeeze, so called place-and-hold. Then the fingers are extended actively as far as the plaster allows. For four weeks the patient do this exercise with 10 repetitions, 10 times a day (7-8 repetitions on the first day) with a resting period of 1.5 hours between sessions. After four weeks the plaster is removed and replaced by a splint protecting the wrist in neutral position and the patient adds true active flexion of the fingers to the previous program with 10 repetitions 10 times per day. Six weeks post surgery the splint is removed and flexion and extension of the wrist is initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active mobilisation | Experimental | Procedure: Active mobilisationThe 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. |
| Passive mobilisation with place and hold | Active comparator | Procedure: Passive mobilisation with place and hold1-3 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Concomitant fracture
- Concomitant soft tissue defect
- Severe crush injury
- Palmar plate injury demanding immobilisation
- Concomitant joint injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active mobilisationWe investigate if active mobilisation is as good as passive mobilisation with place and hold after flexor tendon suture. | Procedure or surgery | Active mobilisation |
| Passive mobilisation with place and holdWe investigate if active mobilisation is as good as passive mobilisation with place and hold after flexor tendon suture. | Procedure or surgery | Passive mobilisation with place and hold |
Primary outcome
Range of motion
Time frame: Up to minimum 5 years after surgery
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.
5 secondary outcomes
Jamar grip strength
Time frame: Up to minimum 5 years after surgery
Key Pinch strength
Time frame: Up to minimum 5 years after surgery
Tendon rerupture
Time frame: Up to minimum 5 years after surgery
Need of secondary operation
Time frame: Up to minimum 5 years after surgery
Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure questionaire
Time frame: Up to minimum 5 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Derived from this study: PubMed 41761199Dahlgren A, Chevalley S, Stromberg J, Bjorkman A. Item-level reanalysis of DASH outcomes after flexor tendon repair using Svensson's non-parametric method. BMC Musculoskelet Disord. 2026 Feb 27;27(1):292. doi: 10.1186/s12891-026-09626-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Fridén, Professor study director
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active mobilisation and Passive mobilisation with place and hold in people with Tendon Injury - Hand, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 26 Jan 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: Up to minimum 5 years after surgery). 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 NCT04385485, which also lists 1 linked publication.
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 26 Jan 2024.