Amniotic Membrane Wrapping and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand/Wrist

Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03013582
• Other study ID #: 16D.538
• Status: Not yet recruiting
• Phase: N/A
• First received: December 20, 2016
• Last updated: January 4, 2017
• Start date: January 2017

Study information

• Verified date: January 2017
• Source: Thomas Jefferson University
• Contact: Michael P Gaspar, MD
• Email: michaelpgaspar[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients deemed candidates for operative tenolysis of the hand or wrist

• Age =18

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesions Nos Postoperative
• Fibrosis
• Scar
• Tendinopathy
• Tissue Adhesions

Intervention

Biological:
• Amnion Tendon Wrapping
Tendon is wrapped with the allograft

Procedure:
• Surgical Tenolysis
Surgical release of peritendinous scarred tissue

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

References & Publications (8)

Branford 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. — View Citation

Fairbairn 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. Review. — View Citation

Gaspar 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. — View Citation

Kohanzadeh 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. — View Citation

Ozbölük S, Ozkan Y, Oztürk A, Gül 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. — View Citation

Rouhani 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. — View Citation

Vucekovich K, Gallardo G, Fiala K. Rehabilitation after flexor tendon repair, reconstruction, and tenolysis. Hand Clin. 2005 May;21(2):257-65. Review. — View Citation

Wu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Active Motion (TAM)		6 months	No
Primary	Passive Range of Motion (PROM)		6 months	No
Secondary	Patient-Rated Wrist Evaluation (PRWE)	Validated Outcome score/questionnaire specific to wrist function	6 months	No
Secondary	Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)	Validated Outcome score/questionnaire generalized to upper extremity conditions	6 months	No
Secondary	Complications		2 weeks, One month, 3 months, 6 months	Yes