TendinopathyNCT03013582
Amniotic Membrane Wrapping and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand/Wrist
A study testing Amnion Tendon Wrapping and Surgical Tenolysis in people with Tendinopathy and Adhesions Nos Postoperative, run by Thomas Jefferson University.
Trial summary
Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand therapists alike. Despite their commonality, no consensus exists as to the best means of preventing adhesions, or the most ideal methods to treat them once they have occurred. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendinopathy, Adhesions Nos Postoperative, Scar
- What is being tested?
- Amnion Tendon Wrapping and Surgical Tenolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients deemed candidates for operative tenolysis of the hand or wrist
- Age ≥18
Who cannot join
- Patients younger than 18 years at the time of surgery;
- Any patient who would not be able or willing to comply with the protocol or perform assessments;
- Patients with medical conditions that may preclude placement of human biological membrane;
- Patients who have previously undergone tenolysis on the operative hand;
- Patients that will have multiple surgeries that are deemed as possible confounders, particularly those requiring an additional incision;
- Is physically or mentally compromised (i.e. being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to participate in the clinical study;
- Is a prisoner;
- Is a transient.
Trial locations and contacts
No sites are listed yet.
Michael P Gaspar, MD contact
About this study
Official title: A Prospective Randomized Trial Comparing Tendon Wrapping With Amniotic Membrane and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand and Wrist
Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand therapists alike. Despite their commonality, no consensus exists as to the best means of preventing adhesions, or the most ideal methods to treat them once they have occurred. The purpose of this study is to compare patient outcomes after standard operative tenolysis performed for adhesions of the hand to outcomes after tenolysis with the use of allograft human amniotic membrane.
Read the detailed description
Patients who are scheduled to undergo operative tenolysis of the flexor and/or extensor tendons of the hand will be recruited. Our target enrollment is 40 patients (20 control plus 20 experimental), based on the power analysis detailed in the next paragraph. Enrolled patients will be randomized to either standard operative tenolysis, or tenolysis with placement of AlloWrap. Randomization will be performed by computerized random number generator. All surgeries will be performed by one senior fellowship-trained hand surgeon. Baseline measurements of total active motion (TAM), passive range of motion (PROM), and survey scores of the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and Patient Rated Wrist Evaluation (PRWE) will be recorded pre-operatively. In addition, patients' pain level will be assessed using the visual analog scale (VAS) both at rest, and during the examination. These same values will be re-evaluated at post-operative follow-up visits at 2 weeks, 1 month, 3 months and 6 months. PROM will also be evaluated intra-operatively by the surgeon, and documented.
- Conditions
- Tendinopathy, Adhesions Nos Postoperative, Scar, Fibrosis
- Being tested
- Amnion Tendon Wrapping, Surgical Tenolysis
- Medical subject headings
- Tendinopathy, Cicatrix, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnion Tendon WrappingBiological
Tendon is wrapped with the allograft
Surgical TenolysisProcedure or surgery
Surgical release of peritendinous scarred tissue
| Study group | Role | What they receive |
|---|---|---|
| Amnion wrapping + Tenolysis | Experimental | Standard surgical tenolysis + wrapping of the released tendon with amnion. Receives: Biological: Amnion Tendon Wrapping; Procedure: Surgical Tenolysis |
| Tenolysis control | Placebo comparator | Standard surgical tenolysis alone Receives: Procedure: Surgical Tenolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Active Motion (TAM)
Measured: 6 months
Passive Range of Motion (PROM)
Measured: 6 months
Secondary outcomes (3)
Patient-Rated Wrist Evaluation (PRWE)
Validated Outcome score/questionnaire specific to wrist function
Measured: 6 months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Validated Outcome score/questionnaire generalized to upper extremity conditions
Measured: 6 months
Complications
Measured: 2 weeks, One month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall W Culp, MD, Principal investigator, Thomas Jefferson University-Philadelphia Hand CenterMichael P Gaspar, MD, Study director, Thomas Jefferson University-Philadelphia Hand Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013582
- Sponsor's protocol ID
- 16D.538
- Status last verified
- Jan 2017
- First submitted
- 20 Dec 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
Publications
Vucekovich K, Gallardo G, Fiala K. Rehabilitation after flexor tendon repair, reconstruction, and tenolysis. Hand Clin. 2005 May;21(2):257-65. doi: 10.1016/j.hcl.2004.11.006.
PubMed 15882604Rouhani A, Tabrizi A, Ghavidel E. Effects of non-steroidal anti-inflammatory drugs on flexor tendon rehabilitation after repair. Arch Bone Jt Surg. 2013 Sep;1(1):28-30. Epub 2013 Sep 15.
PubMed 25207280Kohanzadeh S, Lugo L, Long JN. Safety of antiadhesion barriers in hand surgery. Ann Plast Surg. 2013 May;70(5):527-9. doi: 10.1097/SAP.0b013e31827eace2.
PubMed 23542850Fairbairn NG, Randolph MA, Redmond RW. The clinical applications of human amnion in plastic surgery. J Plast Reconstr Aesthet Surg. 2014 May;67(5):662-75. doi: 10.1016/j.bjps.2014.01.031. Epub 2014 Jan 31.
PubMed 24560801Wu YF, Tang JB. Apoptosis in adhesions and the adhesion-tendon gliding interface: relationship to adhesion-tendon gliding mechanics. J Hand Surg Am. 2013 Jun;38(6):1071-8. doi: 10.1016/j.jhsa.2013.03.012. Epub 2013 May 6.
PubMed 23660197Ozboluk S, Ozkan Y, Ozturk A, Gul N, Ozdemir RM, Yanik K. The effects of human amniotic membrane and periosteal autograft on tendon healing: experimental study in rabbits. J Hand Surg Eur Vol. 2010 May;35(4):262-8. doi: 10.1177/1753193409337961. Epub 2009 Aug 17.
PubMed 19687075Branford OA, Lee DA, Bader DL, Grobbelaar AO. The mechanics of flexor tendon adhesions. J Hand Surg Eur Vol. 2012 Jul;37(6):555-63. doi: 10.1177/1753193411432675. Epub 2011 Dec 14.
PubMed 22170243Gaspar MP, Abdelfattah HM, Welch IW, Vosbikian MM, Kane PM, Rekant MS. Recurrent cubital tunnel syndrome treated with revision neurolysis and amniotic membrane nerve wrapping. J Shoulder Elbow Surg. 2016 Dec;25(12):2057-2065. doi: 10.1016/j.jse.2016.09.013. Epub 2016 Oct 14.
PubMed 27751716
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Tendon Wrapping With Amniotic Membrane and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand and Wrist
- ClinicalTrials.gov ID
- NCT03013582
- Acronym / sponsor ID
- 16D.538
- Conditions
- Tendinopathy, Adhesions Nos Postoperative, Scar, Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jul 2018 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- 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.
Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand therapists alike. Despite their commonality, no consensus exists as to the best means of preventing adhesions, or the most ideal methods to treat them once they have occurred. The purpose of this study is to compare patient outcomes after standard operative tenolysis performed for adhesions of the hand to outcomes after tenolysis with the use of allograft human amniotic membrane.
Detailed description
Patients who are scheduled to undergo operative tenolysis of the flexor and/or extensor tendons of the hand will be recruited. Our target enrollment is 40 patients (20 control plus 20 experimental), based on the power analysis detailed in the next paragraph. Enrolled patients will be randomized to either standard operative tenolysis, or tenolysis with placement of AlloWrap. Randomization will be performed by computerized random number generator. All surgeries will be performed by one senior fellowship-trained hand surgeon. Baseline measurements of total active motion (TAM), passive range of motion (PROM), and survey scores of the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and Patient Rated Wrist Evaluation (PRWE) will be recorded pre-operatively. In addition, patients' pain level will be assessed using the visual analog scale (VAS) both at rest, and during the examination. These same values will be re-evaluated at post-operative follow-up visits at 2 weeks, 1 month, 3 months and 6 months. PROM will also be evaluated intra-operatively by the surgeon, and documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amnion wrapping + Tenolysis | Experimental | Biological: Amnion Tendon Wrapping, Procedure: Surgical TenolysisStandard surgical tenolysis + wrapping of the released tendon with amnion. |
| Tenolysis control | Placebo comparator | Procedure: Surgical TenolysisStandard surgical tenolysis alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients deemed candidates for operative tenolysis of the hand or wrist
- Age ≥18
Key exclusion criteria (8 listed)
- Patients younger than 18 years at the time of surgery;
- Any patient who would not be able or willing to comply with the protocol or perform assessments;
- Patients with medical conditions that may preclude placement of human biological membrane;
- Patients who have previously undergone tenolysis on the operative hand;
- Patients that will have multiple surgeries that are deemed as possible confounders, particularly those requiring an additional incision;
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 |
|---|---|---|
| Amnion Tendon WrappingTendon is wrapped with the allograft | Biological | Amnion wrapping + Tenolysis |
| Surgical TenolysisSurgical release of peritendinous scarred tissue | Procedure or surgery | Amnion wrapping + Tenolysis, Tenolysis control |
Primary outcome
Total Active Motion (TAM)
Time frame: 6 months
Passive Range of Motion (PROM)
Time frame: 6 months
3 secondary outcomes
Patient-Rated Wrist Evaluation (PRWE)
Time frame: 6 months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time frame: 6 months
Complications
Time frame: 2 weeks, One month, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Background: PubMed 15882604Vucekovich K, Gallardo G, Fiala K. Rehabilitation after flexor tendon repair, reconstruction, and tenolysis. Hand Clin. 2005 May;21(2):257-65. doi: 10.1016/j.hcl.2004.11.006.
- Background: PubMed 25207280Rouhani A, Tabrizi A, Ghavidel E. Effects of non-steroidal anti-inflammatory drugs on flexor tendon rehabilitation after repair. Arch Bone Jt Surg. 2013 Sep;1(1):28-30. Epub 2013 Sep 15.
- Background: PubMed 23542850Kohanzadeh S, Lugo L, Long JN. Safety of antiadhesion barriers in hand surgery. Ann Plast Surg. 2013 May;70(5):527-9. doi: 10.1097/SAP.0b013e31827eace2.
- Background: PubMed 24560801Fairbairn NG, Randolph MA, Redmond RW. The clinical applications of human amnion in plastic surgery. J Plast Reconstr Aesthet Surg. 2014 May;67(5):662-75. doi: 10.1016/j.bjps.2014.01.031. Epub 2014 Jan 31.
- Background: PubMed 23660197Wu YF, Tang JB. Apoptosis in adhesions and the adhesion-tendon gliding interface: relationship to adhesion-tendon gliding mechanics. J Hand Surg Am. 2013 Jun;38(6):1071-8. doi: 10.1016/j.jhsa.2013.03.012. Epub 2013 May 6.
- Background: PubMed 19687075Ozboluk S, Ozkan Y, Ozturk A, Gul N, Ozdemir RM, Yanik K. The effects of human amniotic membrane and periosteal autograft on tendon healing: experimental study in rabbits. J Hand Surg Eur Vol. 2010 May;35(4):262-8. doi: 10.1177/1753193409337961. Epub 2009 Aug 17.
- Background: PubMed 22170243Branford OA, Lee DA, Bader DL, Grobbelaar AO. The mechanics of flexor tendon adhesions. J Hand Surg Eur Vol. 2012 Jul;37(6):555-63. doi: 10.1177/1753193411432675. Epub 2011 Dec 14.
- Background: PubMed 27751716Gaspar MP, Abdelfattah HM, Welch IW, Vosbikian MM, Kane PM, Rekant MS. Recurrent cubital tunnel syndrome treated with revision neurolysis and amniotic membrane nerve wrapping. J Shoulder Elbow Surg. 2016 Dec;25(12):2057-2065. doi: 10.1016/j.jse.2016.09.013. Epub 2016 Oct 14.
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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.
Michael P Gaspar, MD contact
Randall W Culp, MD principal investigator
Thomas Jefferson University-Philadelphia Hand Center
Michael P Gaspar, MD study director
Thomas Jefferson University-Philadelphia Hand Center
Questions about this trial
What is this clinical trial studying?
A study testing Amnion Tendon Wrapping and Surgical Tenolysis in people with Tendinopathy and Adhesions Nos Postoperative, run by Thomas Jefferson University.
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 2 inclusion and 8 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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Michael P Gaspar, MD (michaelpgaspar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Active Motion (TAM) (time frame: 6 months). The study lists 2 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 NCT03013582, which also lists 8 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 6 Jan 2017.